Colorectal Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. It is not yet known whether giving tegafur-uracil together with
leucovorin is more effective than giving S-1 in treating patients with stage III colon
cancer.
PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with
leucovorin to see how well it works compared with giving S-1 in treating patients with stage
III colon cancer that has been completely removed by surgery.
OBJECTIVES:
- Compare the disease-free survival of patients with stage III colon cancer treated with
S-1 or tegafur-uracil and leucovorin after curative surgery .
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tegafur-uracil and oral leucovorin 3 times daily on days
1-21. The treatment repeats 5 times every 5 weeks.
- Arm II: Patients receive oral S-1 twice daily on days 1-28. The treatment repeats 4
times every 6 weeks.
Biological samples are collected for gene expression analysis for identification of
predictive markers.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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