Trial Outcomes & Findings for Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer (NCT NCT01196390)
NCT ID: NCT01196390
Last Updated: 2023-09-07
Results Overview
A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
203 participants
Primary outcome timeframe
From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.
Results posted on
2023-09-07
Participant Flow
After registration, sites were required to submit participant tumor tissue for central human epidermal growth factor receptor 2 (HER2) testing. Only HER2-positive participants continued to randomization. In total, 571 participants were registered and 203 were randomized.
Participant milestones
| Measure |
Chemoradiation and Trastuzumab
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
101
|
|
Overall Study
Eligible
|
98
|
96
|
|
Overall Study
Eligible and Started Study Treatment
|
95
|
96
|
|
Overall Study
Eligible and Had Surgery
|
82
|
78
|
|
Overall Study
Eligible and Consented to Quality of Life Component
|
88
|
83
|
|
Overall Study
COMPLETED
|
98
|
96
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Chemoradiation and Trastuzumab
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
5
|
Baseline Characteristics
Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Chemoradiation and Trastuzumab
n=98 Participants
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation
n=96 Participants
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≤ 39 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
40 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Customized
≥ 80 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Zubrod Performance Status
0
|
62 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Zubrod Performance Status
1
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Zubrod Performance Status
2
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
T stage, clinical
T1
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
T stage, clinical
T2
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
T stage, clinical
T3
|
79 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
N stage, clinical
N0
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
N stage, clinical
N1
|
55 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
N stage, clinical
N2
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Presence of Adenopathy
No
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Presence of Adenopathy
Yes adenopathy, but celiac absent
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Presence of Adenopathy
Yes adenopathy and celiac present ≤ 2 cm
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.Population: Eligible randomized participants
A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported.
Outcome measures
| Measure |
Chemoradiation and Trastuzumab (Arm 1)
n=98 Participants
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation (Arm 2)
n=96 Participants
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
|---|---|---|
|
Disease-free Survival (DFS)
|
19.6 months
Interval 13.5 to 26.2
|
14.2 months
Interval 10.5 to 23.0
|
SECONDARY outcome
Timeframe: At the time of surgery, 5-8 weeks after completion of radiation therapy.Population: Eligible participants who had surgery
Pathologic Complete Response (pCR) is evaluated after surgery and is based on the pathology review of the submitted surgical specimen. Pathologic Complete Response occurs if the pathologist determines that the resected esophageal specimen, accompanying lymph nodes, and surgical margins are all free of tumor.
Outcome measures
| Measure |
Chemoradiation and Trastuzumab (Arm 1)
n=82 Participants
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation (Arm 2)
n=78 Participants
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
|---|---|---|
|
Percentage of Participants With Pathologic Complete Response at Surgery
|
27 percentage of participants
Interval 18.0 to 38.0
|
29 percentage of participants
Interval 20.0 to 41.0
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.Population: Eligible randomized participants
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 109 deaths were reported.
Outcome measures
| Measure |
Chemoradiation and Trastuzumab (Arm 1)
n=98 Participants
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation (Arm 2)
n=96 Participants
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
|---|---|---|
|
Overall Survival
|
38.5 months
Interval 26.2 to 70.4
|
38.9 months
Interval 29.0 to 64.5
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.Population: Eligible participants who started study treatment
Common Terminology Criteria for Adverse Events (version 4.0 before 4-1-2018; then version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data provided is in this outcome measure; see Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
Chemoradiation and Trastuzumab (Arm 1)
n=95 Participants
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation (Arm 2)
n=96 Participants
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
|---|---|---|
|
Frequency of Highest Grade Adverse Event Per Participant
All Adverse Events · Grade 1
|
0 Participants
|
0 Participants
|
|
Frequency of Highest Grade Adverse Event Per Participant
All Adverse Events · Grade 2
|
14 Participants
|
12 Participants
|
|
Frequency of Highest Grade Adverse Event Per Participant
All Adverse Events · Grade 3
|
49 Participants
|
56 Participants
|
|
Frequency of Highest Grade Adverse Event Per Participant
All Adverse Events · Grade 4
|
27 Participants
|
25 Participants
|
|
Frequency of Highest Grade Adverse Event Per Participant
All Adverse Events · Grade 5
|
5 Participants
|
3 Participants
|
|
Frequency of Highest Grade Adverse Event Per Participant
Reported as Definitely, Probably, or Possibly Related to Protocol Treatment · Grade 1
|
2 Participants
|
0 Participants
|
|
Frequency of Highest Grade Adverse Event Per Participant
Reported as Definitely, Probably, or Possibly Related to Protocol Treatment · Grade 2
|
27 Participants
|
20 Participants
|
|
Frequency of Highest Grade Adverse Event Per Participant
Reported as Definitely, Probably, or Possibly Related to Protocol Treatment · Grade 3
|
41 Participants
|
52 Participants
|
|
Frequency of Highest Grade Adverse Event Per Participant
Reported as Definitely, Probably, or Possibly Related to Protocol Treatment · Grade 4
|
20 Participants
|
21 Participants
|
|
Frequency of Highest Grade Adverse Event Per Participant
Reported as Definitely, Probably, or Possibly Related to Protocol Treatment · Grade 5
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment startPopulation: Eligible participants who consented to quality of life evaluation and who had baseline and time point data.
The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer with a total score ranging from 0-68. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). A higher score indicates better QOL. Improvement is defined as an increase from the baseline score of at least 5 points.
Outcome measures
| Measure |
Chemoradiation and Trastuzumab (Arm 1)
n=88 Participants
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation (Arm 2)
n=83 Participants
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
|---|---|---|
|
Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment
6-8 weeks from end of treatment
|
46 percentage of participants
Interval 33.0 to 60.0
|
38 percentage of participants
Interval 26.0 to 51.0
|
|
Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment
1 year from start of treatment
|
39 percentage of participants
Interval 26.0 to 53.0
|
42 percentage of participants
Interval 27.0 to 58.0
|
|
Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment
2 years from start of treatment
|
41 percentage of participants
Interval 23.0 to 61.0
|
27 percentage of participants
Interval 14.0 to 45.0
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years.Population: The protocol states that this outcome measure will be analyzed only if primary outcome results are positive, i.e. support the primary hypothesis of this study. Therefore no participants were analyzed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years.Population: The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.Population: Eligible participants who started study treatment
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event (AE) severity from 1=mild to 5=death. Logistic regression was used to evaluate treatment arm, clinical tumor stage (T stage), Zubrod Performance Status, gender, presence of adenopathy, and age as possible predictors of cardiac adverse events. Results of the final model are reported in the statistical analysis section. Summary adverse event data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
Chemoradiation and Trastuzumab (Arm 1)
n=95 Participants
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation (Arm 2)
n=96 Participants
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
|---|---|---|
|
Number of Participants With Any Cardiac Adverse Events Regardless of Attribution
|
30 Participants
|
24 Participants
|
Adverse Events
Chemoradiation and Trastuzumab
Serious events: 51 serious events
Other events: 95 other events
Deaths: 53 deaths
Chemoradiation
Serious events: 34 serious events
Other events: 96 other events
Deaths: 55 deaths
Serious adverse events
| Measure |
Chemoradiation and Trastuzumab
n=95 participants at risk
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation
n=96 participants at risk
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
2.1%
2/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Atrial flutter
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Sinus tachycardia
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Esophageal fistula
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Esophageal perforation
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Esophagitis
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
2.1%
2/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Malabsorption
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
6.2%
6/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Chills
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Death NOS
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Fatigue
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Fever
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Infusion related reaction
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Multi-organ failure
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
2.1%
2/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Pain
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Sudden death NOS
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Catheter related infection
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Lung infection
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Pleural infection
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Sepsis
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
2.1%
2/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Stoma site infection
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Wound infection
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Cardiac troponin I increased
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Lymphocyte count decreased
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Neutrophil count decreased
|
4.2%
4/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Platelet count decreased
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Urine output decreased
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Weight loss
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
White blood cell decreased
|
4.2%
4/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
5.2%
5/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
5/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
10.4%
10/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
2.1%
2/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Nervous system disorders
Cognitive disturbance
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Nervous system disorders
Headache
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Nervous system disorders
Seizure
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Nervous system disorders
Stroke
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Nervous system disorders
Syncope
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Psychiatric disorders
Delirium
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
2.1%
2/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Vascular disorders
Hypertension
|
1.1%
1/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
0.00%
0/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Vascular disorders
Hypotension
|
5.3%
5/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
2.1%
2/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Vascular disorders
Thromboembolic event
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
2.1%
2/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Vascular disorders
Visceral arterial ischemia
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
Other adverse events
| Measure |
Chemoradiation and Trastuzumab
n=95 participants at risk
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
|
Chemoradiation
n=96 participants at risk
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
64.2%
61/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
59.4%
57/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
5/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
5.2%
5/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Cardiac disorders
Sinus tachycardia
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
9.4%
9/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
29.5%
28/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
32.3%
31/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Bloating
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
6.2%
6/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
38/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
46.9%
45/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Diarrhea
|
44.2%
42/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
37.5%
36/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Dry mouth
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
7.3%
7/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
28.4%
27/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
16.7%
16/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Dysphagia
|
60.0%
57/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
52.1%
50/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Esophageal pain
|
13.7%
13/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
13.5%
13/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
8.4%
8/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Esophagitis
|
54.7%
52/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
42.7%
41/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Gastritis
|
7.4%
7/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
19/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
11.5%
11/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
13.7%
13/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
11.5%
11/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
1.0%
1/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
13.7%
13/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
14.6%
14/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Nausea
|
69.5%
66/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
71.9%
69/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Gastrointestinal disorders
Vomiting
|
33.7%
32/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
34.4%
33/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Chills
|
12.6%
12/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
11.5%
11/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Edema limbs
|
13.7%
13/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
7.3%
7/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Fatigue
|
82.1%
78/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
74.0%
71/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Fever
|
12.6%
12/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
11.5%
11/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.4%
7/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
2.1%
2/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Infusion related reaction
|
8.4%
8/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
6.2%
6/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Non-cardiac chest pain
|
8.4%
8/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
7.3%
7/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
General disorders
Pain
|
23.2%
22/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
18.8%
18/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Lung infection
|
4.2%
4/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
6.2%
6/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Skin infection
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
5.2%
5/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Upper respiratory infection
|
8.4%
8/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
5/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
8.4%
8/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
10.4%
10/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Alanine aminotransferase increased
|
10.5%
10/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
9.4%
9/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Alkaline phosphatase increased
|
15.8%
15/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
8.3%
8/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Aspartate aminotransferase increased
|
16.8%
16/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
9.4%
9/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Blood bilirubin increased
|
5.3%
5/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
8.3%
8/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Creatinine increased
|
3.2%
3/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
5.2%
5/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Lymphocyte count decreased
|
42.1%
40/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
38.5%
37/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Neutrophil count decreased
|
49.5%
47/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
52.1%
50/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Platelet count decreased
|
61.1%
58/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
66.7%
64/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
Weight loss
|
47.4%
45/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
46.9%
45/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Investigations
White blood cell decreased
|
82.1%
78/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
84.4%
81/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
43.2%
41/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
47.9%
46/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.3%
24/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
22.9%
22/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
38.9%
37/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
32.3%
31/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
7.3%
7/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
27.4%
26/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
27.1%
26/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
21.1%
20/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
19.8%
19/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.8%
15/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
17.7%
17/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.3%
5/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
11.5%
11/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.6%
31/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
25.0%
24/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
5.2%
5/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
7/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.6%
12/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
18.8%
18/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.5%
10/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
10.4%
10/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Nervous system disorders
Dizziness
|
21.1%
20/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
15.6%
15/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Nervous system disorders
Dysgeusia
|
13.7%
13/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
19.8%
19/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Nervous system disorders
Headache
|
10.5%
10/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
12.5%
12/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.9%
17/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
18.8%
18/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Psychiatric disorders
Anxiety
|
18.9%
18/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
12.5%
12/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Psychiatric disorders
Depression
|
10.5%
10/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
10.4%
10/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Psychiatric disorders
Insomnia
|
18.9%
18/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
24.0%
23/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
6.2%
6/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
20/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
25.0%
24/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
34.7%
33/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
21.9%
21/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.3%
6/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
11.5%
11/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
6.2%
6/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.4%
7/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
7.3%
7/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.6%
11/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
8.3%
8/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.3%
5/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
5/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
10.4%
10/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
9.5%
9/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
4.2%
4/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.4%
8/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
3.1%
3/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.5%
10/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
11.5%
11/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
5/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
5.2%
5/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
4/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
5.2%
5/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.5%
10/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
14.6%
14/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
13.7%
13/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
2.1%
2/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Vascular disorders
Hypertension
|
8.4%
8/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
15.6%
15/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Vascular disorders
Hypotension
|
13.7%
13/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
14.6%
14/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
|
Vascular disorders
Thromboembolic event
|
2.1%
2/95 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
6.2%
6/96 • Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60