Trial Outcomes & Findings for Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer (NCT NCT00807911)
NCT ID: NCT00807911
Last Updated: 2024-10-23
Results Overview
Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
322 participants
Primary outcome timeframe
up to 3 years after completion of treatment
Results posted on
2024-10-23
Participant Flow
1 screening failure due to raised carcinoembryonic antigen concentration
Participant milestones
| Measure |
Adjuvant Fluorouracil +Leucovorin
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
Adjuvant FL: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
|
Adjuvant FOLFOX
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
Adjuvant FOLFOX: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
160
|
|
Overall Study
COMPLETED
|
149
|
146
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
Reasons for withdrawal
| Measure |
Adjuvant Fluorouracil +Leucovorin
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
Adjuvant FL: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
|
Adjuvant FOLFOX
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
Adjuvant FOLFOX: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
10
|
|
Overall Study
Ineligible
|
0
|
4
|
Baseline Characteristics
Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer
Baseline characteristics by cohort
| Measure |
Adjuvant Fluorouracil +Leucovorin
n=161 Participants
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
Adjuvant FL: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
|
Adjuvant FOLFOX
n=160 Participants
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
Adjuvant FOLFOX: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
55 years
n=7 Participants
|
54.5 years
n=5 Participants
|
|
Age, Customized
Aged 65 years or older
|
24 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
|
ECOG PS
0
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
ECOG PS
1
|
131 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
|
Distance of the primary tumour from the anal verge
≤4 cm
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Distance of the primary tumour from the anal verge
>4 and ≤8 cm
|
89 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Distance of the primary tumour from the anal verge
>8 cm
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Tumor differentiation
Well differentiated
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Tumor differentiation
Moderately differentiated
|
130 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
|
Tumor differentiation
Poorly differentiated/signet ring cell/mucinous
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Tumor differentiation
Undetermined
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Preoperative radiotherapy Dose
|
5000 cGY
n=5 Participants
|
5000 cGY
n=7 Participants
|
5000 cGY
n=5 Participants
|
|
Preoperative radiotherapy duration
|
5.0 weeks
n=5 Participants
|
5.1 weeks
n=7 Participants
|
5.05 weeks
n=5 Participants
|
|
Concurrent chemotherapy during preoperative radiotherapy
Fluorouracil with or without leucovorin
|
108 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Concurrent chemotherapy during preoperative radiotherapy
Capecitabine
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Concurrent chemotherapy during preoperative radiotherapy
Tegafur-uracil
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Concurrent chemotherapy during preoperative radiotherapy
|
7.0 weeks
n=5 Participants
|
7.0 weeks
n=7 Participants
|
7.0 weeks
n=5 Participants
|
|
Type of surgery
Abdominoperineal resection
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Type of surgery
Low anterior resection
|
135 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Type of surgery
Hartmann's procedure
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Pathological T stage
ypT0
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Pathological T stage
ypT1
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Pathological T stage
ypT2
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Pathological T stage
ypT3
|
131 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Pathological T stage
ypT4
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Pathological N stage
ypN0
|
65 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Pathological N stage
ypN1a
|
30 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Pathological N stage
ypN1b
|
38 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Pathological N stage
ypN2a
|
19 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Pathological N stage
ypN2b
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
yp stage
II
|
65 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
yp stage
III
|
96 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Grade of tumour regression
Total regression
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Grade of tumour regression
Near total regression
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Grade of tumour regression
Moderate regression
|
84 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Grade of tumour regression
Minimal or no regression
|
52 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Grade of tumour regression
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Lymphovascular invasion
Absent
|
120 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Lymphovascular invasion
Present
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Lymphovascular invasion
Unknown
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Time from surgery to randomisation (weeks)
|
3.6 weeks
n=5 Participants
|
3.4 weeks
n=7 Participants
|
3.5 weeks
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 years after completion of treatmentPopulation: intention-to-treat population (all randomised patients)
Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria
Outcome measures
| Measure |
Adjuvant Fluorouracil +Leucovorin
n=161 Participants
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
Adjuvant FL: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
|
Adjuvant FOLFOX
n=160 Participants
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
Adjuvant FOLFOX: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
|
|---|---|---|
|
Number of Participants With Disease Recurrence
|
53 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: up to 3 years after completion of treatmentPopulation: Among intention-to-treat population (all randomised patients), Patients with pathological stage III disease
Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria.
Outcome measures
| Measure |
Adjuvant Fluorouracil +Leucovorin
n=96 Participants
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
Adjuvant FL: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
|
Adjuvant FOLFOX
n=102 Participants
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
Adjuvant FOLFOX: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
|
|---|---|---|
|
Number of Participants With Disease Recurrence With Pathological Stage III
|
38 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: up to 3 years after completion of treatmentPopulation: Among intention-to-treat population (all randomised patients), Patients with pathological stage II disease
Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria.
Outcome measures
| Measure |
Adjuvant Fluorouracil +Leucovorin
n=65 Participants
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
Adjuvant FL: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
|
Adjuvant FOLFOX
n=58 Participants
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
Adjuvant FOLFOX: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
|
|---|---|---|
|
Number of Participants With Disease Recurrence With Pathological Stage II
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years after completion of treatment.Population: intention-to-treat population (all randomised patients)
overall survival was defined as the time from randomisation to death. We used the Kaplan-Meier method to estimate disease-free and overall survival. Patients were censored at the last follow-up if they were alive and free from disease recurrence. We used the log-rank test to compare the two survival distributions. We estimated crude and stratified hazard ratios (HRs) and their corresponding 95% CIs using the Cox proportionalhazards regression model.
Outcome measures
| Measure |
Adjuvant Fluorouracil +Leucovorin
n=161 Participants
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
Adjuvant FL: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
|
Adjuvant FOLFOX
n=160 Participants
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
Adjuvant FOLFOX: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
|
|---|---|---|
|
Death Rate
|
21 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: the time from the date of randomization to the date of disease relapse, , assessed up to 5 yearsPopulation: intention-to-treat population (all randomised patients)
After the completion of study treatment, chest radiography and measurement of carcinoembryonic antigen were done every 3 months for the fi rst 2 years and every 6 months thereafter. Abdominopelvic CT scans were done every 6 months and chest CT scans annually. Colonoscopy was scheduled at 1 year, 3 years, and 5 years from the date of surgery. Local recurrence was defined as any clinically proven tumour relapse within the pelvis or perineum. Distant metastasis was defined as relapse at any other site rather than local recurrence. We regarded any local or distant recurrence as a disease recurrence event. Disease recurrence was judged by the investigators with no central review.
Outcome measures
| Measure |
Adjuvant Fluorouracil +Leucovorin
n=161 Participants
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
Adjuvant FL: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
|
Adjuvant FOLFOX
n=160 Participants
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
Adjuvant FOLFOX: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
|
|---|---|---|
|
Pattern of Recurrence
Any event
|
53 Participants
|
39 Participants
|
|
Pattern of Recurrence
Local recurrence
|
12 Participants
|
5 Participants
|
|
Pattern of Recurrence
Distant metastasis
|
44 Participants
|
35 Participants
|
|
Pattern of Recurrence
Lung
|
29 Participants
|
24 Participants
|
|
Pattern of Recurrence
Liver
|
15 Participants
|
8 Participants
|
|
Pattern of Recurrence
Lymph node
|
10 Participants
|
6 Participants
|
|
Pattern of Recurrence
Bone
|
4 Participants
|
2 Participants
|
|
Pattern of Recurrence
Peritoneum
|
1 Participants
|
1 Participants
|
|
Pattern of Recurrence
Other*
|
2 Participants
|
2 Participants
|
Adverse Events
Fluorouracil+Leucovorin Group
Serious events: 0 serious events
Other events: 149 other events
Deaths: 21 deaths
FOLFOX Group
Serious events: 0 serious events
Other events: 146 other events
Deaths: 10 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluorouracil+Leucovorin Group
n=149 participants at risk
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles) Adjuvant FL: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
|
FOLFOX Group
n=146 participants at risk
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles) Adjuvant FOLFOX: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
22.1%
33/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
32.2%
47/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Blood and lymphatic system disorders
neutropenia
|
45.6%
68/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
69.9%
102/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
4/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
0.68%
1/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
3/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
26.0%
38/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
3/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
2.1%
3/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
General disorders
Fatigue
|
17.4%
26/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
28.1%
41/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.8%
28/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
12.3%
18/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Gastrointestinal disorders
Nausea
|
37.6%
56/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
53.4%
78/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
17/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
13.0%
19/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Gastrointestinal disorders
Stomatitis
|
42.3%
63/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
32.2%
47/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Gastrointestinal disorders
Diarrhea
|
25.5%
38/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
33.6%
49/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Immune system disorders
Allergic reaction
|
0.67%
1/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
2.1%
3/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
|
Nervous system disorders
Sensory neuropathy
|
5.4%
8/149 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
70.5%
103/146 • 3 years
12 patients in the fluorouracil plus leucovorin group and 10 in the FOLFOX group were not received the planned treatment because of withdrawal. 4 patient in the FOLFOX group were not received the planned treatment because of ineligible. Death was assessed for all randomized participants. Adverse Events were assessed for all treated participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place