Trial Outcomes & Findings for Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer (NCT 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

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

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

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=99 Participants	55 years n=107 Participants	54.5 years n=206 Participants
Age, Customized Aged 65 years or older	24 Participants n=99 Participants	31 Participants n=107 Participants	55 Participants n=206 Participants
Sex: Female, Male Female	45 Participants n=99 Participants	42 Participants n=107 Participants	87 Participants n=206 Participants
Sex: Female, Male Male	116 Participants n=99 Participants	118 Participants n=107 Participants	234 Participants n=206 Participants
ECOG PS 0	30 Participants n=99 Participants	26 Participants n=107 Participants	56 Participants n=206 Participants
ECOG PS 1	131 Participants n=99 Participants	134 Participants n=107 Participants	265 Participants n=206 Participants
Distance of the primary tumour from the anal verge ≤4 cm	45 Participants n=99 Participants	48 Participants n=107 Participants	93 Participants n=206 Participants
Distance of the primary tumour from the anal verge >4 and ≤8 cm	89 Participants n=99 Participants	81 Participants n=107 Participants	170 Participants n=206 Participants
Distance of the primary tumour from the anal verge >8 cm	27 Participants n=99 Participants	31 Participants n=107 Participants	58 Participants n=206 Participants
Tumor differentiation Well differentiated	20 Participants n=99 Participants	13 Participants n=107 Participants	33 Participants n=206 Participants
Tumor differentiation Moderately differentiated	130 Participants n=99 Participants	133 Participants n=107 Participants	263 Participants n=206 Participants
Tumor differentiation Poorly differentiated/signet ring cell/mucinous	9 Participants n=99 Participants	11 Participants n=107 Participants	20 Participants n=206 Participants
Tumor differentiation Undetermined	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Preoperative radiotherapy Dose	5000 cGY n=99 Participants	5000 cGY n=107 Participants	5000 cGY n=206 Participants
Preoperative radiotherapy duration	5.0 weeks n=99 Participants	5.1 weeks n=107 Participants	5.05 weeks n=206 Participants
Concurrent chemotherapy during preoperative radiotherapy Fluorouracil with or without leucovorin	108 Participants n=99 Participants	107 Participants n=107 Participants	215 Participants n=206 Participants
Concurrent chemotherapy during preoperative radiotherapy Capecitabine	43 Participants n=99 Participants	46 Participants n=107 Participants	89 Participants n=206 Participants
Concurrent chemotherapy during preoperative radiotherapy Tegafur-uracil	10 Participants n=99 Participants	7 Participants n=107 Participants	17 Participants n=206 Participants
Concurrent chemotherapy during preoperative radiotherapy	7.0 weeks n=99 Participants	7.0 weeks n=107 Participants	7.0 weeks n=206 Participants
Type of surgery Abdominoperineal resection	24 Participants n=99 Participants	24 Participants n=107 Participants	48 Participants n=206 Participants
Type of surgery Low anterior resection	135 Participants n=99 Participants	135 Participants n=107 Participants	270 Participants n=206 Participants
Type of surgery Hartmann's procedure	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Pathological T stage ypT0	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Pathological T stage ypT1	4 Participants n=99 Participants	1 Participants n=107 Participants	5 Participants n=206 Participants
Pathological T stage ypT2	18 Participants n=99 Participants	18 Participants n=107 Participants	36 Participants n=206 Participants
Pathological T stage ypT3	131 Participants n=99 Participants	133 Participants n=107 Participants	264 Participants n=206 Participants
Pathological T stage ypT4	6 Participants n=99 Participants	3 Participants n=107 Participants	9 Participants n=206 Participants
Pathological N stage ypN0	65 Participants n=99 Participants	58 Participants n=107 Participants	123 Participants n=206 Participants
Pathological N stage ypN1a	30 Participants n=99 Participants	42 Participants n=107 Participants	72 Participants n=206 Participants
Pathological N stage ypN1b	38 Participants n=99 Participants	25 Participants n=107 Participants	63 Participants n=206 Participants
Pathological N stage ypN2a	19 Participants n=99 Participants	29 Participants n=107 Participants	48 Participants n=206 Participants
Pathological N stage ypN2b	9 Participants n=99 Participants	6 Participants n=107 Participants	15 Participants n=206 Participants
yp stage II	65 Participants n=99 Participants	58 Participants n=107 Participants	123 Participants n=206 Participants
yp stage III	96 Participants n=99 Participants	102 Participants n=107 Participants	198 Participants n=206 Participants
Grade of tumour regression Total regression	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Grade of tumour regression Near total regression	22 Participants n=99 Participants	31 Participants n=107 Participants	53 Participants n=206 Participants
Grade of tumour regression Moderate regression	84 Participants n=99 Participants	85 Participants n=107 Participants	169 Participants n=206 Participants
Grade of tumour regression Minimal or no regression	52 Participants n=99 Participants	38 Participants n=107 Participants	90 Participants n=206 Participants
Grade of tumour regression Unknown	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Lymphovascular invasion Absent	120 Participants n=99 Participants	120 Participants n=107 Participants	240 Participants n=206 Participants
Lymphovascular invasion Present	41 Participants n=99 Participants	37 Participants n=107 Participants	78 Participants n=206 Participants
Lymphovascular invasion Unknown	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Time from surgery to randomisation (weeks)	3.6 weeks n=99 Participants	3.4 weeks n=107 Participants	3.5 weeks n=206 Participants

PRIMARY outcome

Timeframe: up to 3 years after completion of treatment

Population: intention-to-treat population (all randomised patients)

Outcome measures

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 treatment

Population: Among intention-to-treat population (all randomised patients), Patients with pathological stage III disease

Outcome measures

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 treatment

Population: Among intention-to-treat population (all randomised patients), Patients with pathological stage II disease

Outcome measures

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

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 years

Population: 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

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

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

Dr. Tae Won Kim

Asan Medical Center

Phone: +82-2-3010-3910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place