This trial is active, not recruiting.

Condition rectal cancer
Treatments adjuvant fl, adjuvant folfox
Phase phase 2
Sponsor Asan Medical Center
Start date November 2008
End date July 2014
Trial size 320 participants
Trial identifier NCT00807911, AMC-0256


The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs 5-FU/Leucovorin.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
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 (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

Primary Outcomes

disease-free survival
time frame: 3 year

Secondary Outcomes

overall survival, pattern of failure,safety, quality of life
time frame: 3 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the rectum 2. Patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor. 3. AJCC/UICC pathologic stages of ypT3-4 or ypN+ 4. Curative surgery not less than 3 and not more than 8 weeks prior to randomization 5. No prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer 6. ECOG PS 0-1 7. Adequate organ function 8. Informed Consent Exclusion Criteria: 1. Macroscopic or microscopic evidence of remaining tumor 2. Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease 3. More than 8 weeks after curative surgery

Additional Information

Official title Randomized Phase II Study of Adjuvant Chemotherapy With 5-FU/Leucovorin vs. Oxaliplatin/5-FU/Leucovorin After Preoperative Chemoradiotherapy With Fluoropyrimidines Followed by Surgery in Patients With Locally Advanced Rectal Cancer
Principal investigator Tae Won Kim, Professor
Description Preoperative chemoradiotherapy with fluoropyrimidines followed by surgery is one of the standard treatments for patients with locally advanced rectal cancer; however, the role of adjuvant chemotherapy is still controversial. The aim of this study is to investigate the efficacy of adjuvant FOLFOX for rectal cancer who underwent fluoropyrimidine based chemoradiotherapy and complete total mesorectal excision.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Asan Medical Center.