Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
Recruitment status was Active, not recruiting
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.
Drug: leucovorin calcium
Drug: tegafur-gimeracil-oteracil potassium
Genetic: gene expression analysis
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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|
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Adverse event [ Designated as safety issue: Yes ]
- Pharmaco-economics [ Designated as safety issue: No ]
- Identification of predictive markers [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
- 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 predictive markers.
|Tokyo Medical and Dental University|
|Tokyo, Japan, 113-8519|
|Principal Investigator:||Kenichi Sugihara, MD, PhD||Tokyo Medical and Dental University|