Trial Outcomes & Findings for Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer (NCT NCT00068692)
NCT ID: NCT00068692
Last Updated: 2018-12-04
Results Overview
Overall survival (OS) was defined as time from randomization to death from any cause. 3-year OS rate was estimated using Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
225 participants
Primary outcome timeframe
assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years
Results posted on
2018-12-04
Participant Flow
This study was activated on October 15, 2003. Accrual was suspended on November 26, 2004 and subsequently closed on October 25, 2005 with total accrual of 225 patients to step 1 and 179 patients to step 2.
Participant milestones
| Measure |
Group I, Arm S
Group I patients receive concurrent chemotherapy and radiation prior to surgery.
|
Group II, Arm T
Patients who had surgery before registering to the study was in Group II. They were registered and randomized at the same time.
|
Group I, Arm I
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
Irinotecan: Given IV
|
Group I, Arm II
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
Oxaliplatin: Given IV
|
Group I, Arm III
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
|
Group II, Arm I
Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
Irinotecan: Given IV
|
Group II, Arm II
Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
Oxaliplatin: Given IV
|
Group II, Arm III
Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
|
|---|---|---|---|---|---|---|---|---|
|
Step 1: Registration
STARTED
|
128
|
97
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Started Concurrent Chemo/Radiation
|
125
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Reported AE Data
|
123
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
COMPLETED
|
88
|
96
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
NOT COMPLETED
|
40
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 2: Randomization
STARTED
|
0
|
0
|
28
|
25
|
30
|
31
|
33
|
32
|
|
Step 2: Randomization
Treated
|
0
|
0
|
27
|
25
|
29
|
31
|
33
|
32
|
|
Step 2: Randomization
Had Sphincter Preservation
|
0
|
0
|
28
|
25
|
28
|
31
|
33
|
30
|
|
Step 2: Randomization
Reported AE Data
|
0
|
0
|
27
|
22
|
28
|
31
|
33
|
32
|
|
Step 2: Randomization
COMPLETED
|
0
|
0
|
18
|
13
|
21
|
25
|
29
|
24
|
|
Step 2: Randomization
NOT COMPLETED
|
0
|
0
|
10
|
12
|
9
|
6
|
4
|
8
|
Reasons for withdrawal
| Measure |
Group I, Arm S
Group I patients receive concurrent chemotherapy and radiation prior to surgery.
|
Group II, Arm T
Patients who had surgery before registering to the study was in Group II. They were registered and randomized at the same time.
|
Group I, Arm I
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
Irinotecan: Given IV
|
Group I, Arm II
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
Oxaliplatin: Given IV
|
Group I, Arm III
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
|
Group II, Arm I
Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
Irinotecan: Given IV
|
Group II, Arm II
Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
Oxaliplatin: Given IV
|
Group II, Arm III
Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy
Fluorouracil: Given IV
Leucovorin Calcium: Given IV
|
|---|---|---|---|---|---|---|---|---|
|
Step 1: Registration
Disese progression/relapse
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Adverse Event
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Withdrawal by Subject
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Alternative therapy
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Complicating disease
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Not eligible
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Other
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Not start protocol therapy
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Registration
Registered but not randomized
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 2: Randomization
Disesae progression/replase
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Step 2: Randomization
Adverse Event
|
0
|
0
|
4
|
2
|
2
|
3
|
4
|
4
|
|
Step 2: Randomization
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Step 2: Randomization
Withdrawal by Subject
|
0
|
0
|
4
|
6
|
3
|
2
|
0
|
3
|
|
Step 2: Randomization
alternative therapy
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Step 2: Randomization
Physician Decision
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Step 2: Randomization
Other
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Step 2: Randomization
never start protocol therapy
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer
Baseline characteristics by cohort
| Measure |
Irinocetan (Arm I)
n=59 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin,
|
Oxaliplatin (Arm II)
n=58 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.
|
Control (Arm III)
n=62 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
56 years
n=7 Participants
|
58 years
n=5 Participants
|
57 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 yearsPopulation: All randomized patients
Overall survival (OS) was defined as time from randomization to death from any cause. 3-year OS rate was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Irinocetan (Arm I)
n=59 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin.
|
Oxaliplatin (Arm II)
n=58 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.
|
Control (Arm III)
n=62 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.
|
|---|---|---|---|
|
3-year Overall Survival Rate
|
0.965 proportion of patients
Interval 0.868 to 0.991
|
0.843 proportion of patients
Interval 0.721 to 0.915
|
0.870 proportion of patients
Interval 0.757 to 0.933
|
SECONDARY outcome
Timeframe: assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 yearsPopulation: All randomized patients
Disease free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer and death from any cause, whichever occurred first. 3-year DFS rate was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Irinocetan (Arm I)
n=59 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin.
|
Oxaliplatin (Arm II)
n=58 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.
|
Control (Arm III)
n=62 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.
|
|---|---|---|---|
|
3-year Disease Free Survival
|
0.670 proportion of patients
Interval 0.533 to 0.776
|
0.717 proportion of patients
Interval 0.58 to 0.816
|
0.704 proportion of patients
Interval 0.572 to 0.802
|
SECONDARY outcome
Timeframe: assessed at primary surgery timePopulation: All randomized patients
Proportion of sphincter preservation was defined as number of patients with sphincter preservation divided by total number of patients randomized to the arm
Outcome measures
| Measure |
Irinocetan (Arm I)
n=59 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin.
|
Oxaliplatin (Arm II)
n=58 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.
|
Control (Arm III)
n=58 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.
|
|---|---|---|---|
|
Proportion of Sphincter Preservation
|
0.814 proportion of patients
Interval 0.691 to 0.903
|
0.724 proportion of patients
Interval 0.591 to 0.833
|
0.655 proportion of patients
Interval 0.519 to 0.775
|
SECONDARY outcome
Timeframe: assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 yearsPopulation: All randomized patients
Type of failures (local/regional recurrence vs. distant recurrence vs. concurrent recurrence vs. second primary cancer vs. deaths) in the analysis population
Outcome measures
| Measure |
Irinocetan (Arm I)
n=59 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received irinocetan plus 5-FU and leucovorin.
|
Oxaliplatin (Arm II)
n=58 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group received oxaliplatin plus 5-FU and leucovorin.
|
Control (Arm III)
n=62 Participants
The study was not designed to look at the treatment regimen separately in the two groups. I in Group I and Group II are combined. Patients in this group only received 5-FU and leucovorin.
|
|---|---|---|---|
|
Failure Pattern
Local/regional recurrence only
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Failure Pattern
Distant recurrence only
|
15 Participants
|
11 Participants
|
10 Participants
|
|
Failure Pattern
Both local/regional and distant recurrence
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Failure Pattern
Any recurrence
|
20 Participants
|
20 Participants
|
16 Participants
|
|
Failure Pattern
Second primary cancer
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Failure Pattern
Death
|
19 Participants
|
21 Participants
|
21 Participants
|
Adverse Events
Arm S
Serious events: 62 serious events
Other events: 27 other events
Deaths: 1 deaths
Group I, Arm I
Serious events: 11 serious events
Other events: 7 other events
Deaths: 8 deaths
Group I, Arm II
Serious events: 14 serious events
Other events: 3 other events
Deaths: 12 deaths
Group I, Arm III
Serious events: 10 serious events
Other events: 3 other events
Deaths: 11 deaths
Group II, Arm I
Serious events: 21 serious events
Other events: 6 other events
Deaths: 11 deaths
Group II, Arm II
Serious events: 23 serious events
Other events: 6 other events
Deaths: 9 deaths
Group II, Arm III
Serious events: 23 serious events
Other events: 12 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Arm S
n=123 participants at risk
Preoperative chemo/radiation therapy received by Group I patients in step 1
|
Group I, Arm I
n=27 participants at risk
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV
|
Group I, Arm II
n=22 participants at risk
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV
|
Group I, Arm III
n=28 participants at risk
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV
|
Group II, Arm I
n=31 participants at risk
Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV
|
Group II, Arm II
n=33 participants at risk
Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV
|
Group II, Arm III
n=32 participants at risk
Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV
|
|---|---|---|---|---|---|---|---|
|
Immune system disorders
Allergic reaction
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.1%
2/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Blood and lymphatic system disorders
Anemia
|
1.6%
2/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.5%
2/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Leukocytes decreased
|
1.6%
2/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
14.8%
4/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
18.2%
4/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
7.1%
2/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.7%
3/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
15.2%
5/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.4%
3/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Lymphopenia
|
6.5%
8/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
18.2%
4/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.5%
2/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Neutrophils decreased
|
4.9%
6/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
22.2%
6/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
40.9%
9/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
7.1%
2/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
19.4%
6/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
27.3%
9/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Platelets decreased
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
4.5%
1/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Blood and lymphatic system disorders
Hematologic-other
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Cardiac disorders
Cardiac-ischemia
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Vascular disorders
Hypotension
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
General disorders
Fatigue
|
6.5%
8/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
7.4%
2/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
10.7%
3/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.7%
3/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
12.5%
4/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
General disorders
Fever w/o neutropenia
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Weight loss
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
7.4%
2/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
INR increased
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
2.4%
3/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.5%
2/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.2%
2/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Metabolism and nutrition disorders
Anorexia
|
4.9%
6/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
10.7%
3/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.5%
2/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
12.5%
4/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
6/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
14.3%
4/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.5%
2/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.2%
2/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
26.0%
32/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
11.1%
3/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.1%
2/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
21.4%
6/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
38.7%
12/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
30.3%
10/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
50.0%
16/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Ileus
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Incontinence, anal
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Injury, poisoning and procedural complications
Leak, incl. anastomotic, rectum
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
4.1%
5/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Respiratory, thoracic and mediastinal disorders
Muco/stomatitis by exam, pharynx
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
6.5%
8/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Respiratory, thoracic and mediastinal disorders
Muco/stomatitis (symptom) pharynx
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) rectum
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Nausea
|
3.3%
4/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
11.1%
3/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
7.1%
2/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.5%
2/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.4%
3/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Obstruction, colon
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Obstruction, small bowel NOS
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Proctitis
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
4.5%
1/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
3/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
4.5%
1/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.7%
3/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.4%
3/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
GI-other
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Injury, poisoning and procedural complications
Surgical hemorrhage
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection w/ gr3-4 neut, abdomen NOS
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection w/ gr3-4 neut, pelvis NOS
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection w/ gr3-4 neut, urinary tract
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection Gr0-2 neut, abdomen
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection Gr0-2 neut, catheter
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection Gr0-2 neut, penis
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection Gr0-2 neut, rectum
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection Gr0-2 neut, wound
|
1.6%
2/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection w/ unk ANC rectum
|
1.6%
2/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection Gr0-2 neut, blood
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Infections and infestations
Infection w/ unk ANC blood
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Creatinine increased
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.4%
3/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.1%
2/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.2%
2/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Metabolic/Laboratory-other
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Nervous system disorders
Dizziness
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Nervous system disorders
Neuropathy-motor
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.1%
2/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Nervous system disorders
Syncope
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Abdomen, pain
|
4.1%
5/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
4.5%
1/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
12.9%
4/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.2%
2/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Nervous system disorders
Head/headache
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Nervous system disorders
Neuropathic, pain
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Oral cavity, pain
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
General disorders
Pain NOS
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Rectum, pain
|
4.9%
6/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Renal and urinary disorders
Urethra, pain
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
4.5%
1/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
General disorders
Pain-other
|
1.6%
2/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Respiratory, thoracic and mediastinal disorders
(ARDS)
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.81%
1/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Renal and urinary disorders
Incontinence urinary
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.6%
2/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
Other adverse events
| Measure |
Arm S
n=123 participants at risk
Preoperative chemo/radiation therapy received by Group I patients in step 1
|
Group I, Arm I
n=27 participants at risk
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV
|
Group I, Arm II
n=22 participants at risk
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV
|
Group I, Arm III
n=28 participants at risk
Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV
|
Group II, Arm I
n=31 participants at risk
Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV
|
Group II, Arm II
n=33 participants at risk
Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV
|
Group II, Arm III
n=32 participants at risk
Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.2%
15/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
25.9%
7/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
13.6%
3/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.5%
2/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.1%
2/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
12.5%
4/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Leukocytes decreased
|
5.7%
7/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
14.8%
4/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.1%
2/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.1%
2/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
18.8%
6/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Neutrophils decreased
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
14.8%
4/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
4.5%
1/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.5%
2/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.1%
2/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.2%
2/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Platelets decreased
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.1%
2/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.1%
2/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.2%
2/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
General disorders
Fatigue
|
10.6%
13/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
11.1%
3/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
13.6%
3/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.7%
3/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
12.1%
4/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
25.0%
8/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Investigations
Weight loss
|
6.5%
8/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.7%
7/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.2%
2/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
7.4%
2/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.2%
2/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.1%
2/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
8.1%
10/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
14.8%
4/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
4.5%
1/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.7%
3/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.1%
3/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
15.6%
5/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
5.7%
7/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.5%
2/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.4%
3/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
4.5%
1/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.1%
2/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
12.5%
4/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Nausea
|
8.1%
10/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
14.8%
4/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
13.6%
3/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.1%
3/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
18.8%
6/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
7.4%
2/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.5%
2/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.1%
2/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.1%
1/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.1%
2/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
0.00%
0/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
9.1%
3/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
6.2%
2/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
|
Gastrointestinal disorders
Abdomen, pain
|
0.00%
0/123 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.7%
1/27 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
4.5%
1/22 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.6%
1/28 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.2%
1/31 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
3.0%
1/33 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
15.6%
5/32 • Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60