Randomized Phase III Study of UFT+Leucovorin vs. TS-1 as Adjuvant Treatment for Stage III Colon Cancer , and Investigate Predictive Factors Based on Gene Expression
- Compare the disease-free survival of patients with stage III colon cancer treated with
S-1 or tegafur-uracil and leucovorin calcium after curative surgery .
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tegafur-uracil and oral leucovorin calcium 3 times daily
on days 1-21. Treatment repeats every 5 weeks for up to 5 courses.
- Arm II: Patients receive oral S-1 twice daily on days 1-28. Treatment repeats every 6
weeks for up to 4 courses.
Biological samples are collected for gene expression analysis for identification of
Allocation: Randomized, Primary Purpose: Treatment
Kenichi Sugihara, MD, PhD
Tokyo Medical and Dental University
United States: Federal Government