Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy
for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit
of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial
comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination
chemotherapy, 5-FU+l-LV, in stage III colorectal cancer.
UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five
times every 5 weeks.
5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three
times every 8 weeks.
Primary endpoints are disease-free survival and secondary endpoints are overall survival and
adverse event rate.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
during the study conduct
Yoshihiro Moriya, MD
National Cancer Center Hospital
Japan: Ministry of Health, Labor and Welfare