Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
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.
|Colorectal Cancer||Drug: folinate calcium Drug: tegafur-uracil Drug: tegafur-gimeracil-oteracil potassium||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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
- Overall survival
- Adverse event
- Identification of predictive markers
|Study Start Date:||April 2008|
|Study Completion Date:||July 2015|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: tegafur-gimeracil-oteracil potassium
Patients receive tegafur-gimeracil-oteracil potassium(S-1) orally twice daily for 28 days with a subsequent pause of 14 days. This repeats 4 times every 6 weeks.
Drug: tegafur-gimeracil-oteracil potassium
Other Name: S-1, TS-1
Active Comparator: tegafur-uracil and folinate calcium
Patients receive tegafur-uracil(UFT) plus folinate calcium(leucovorin) orally every 8 hours for 21 days with a subsequent pause of 7 days. This repeats 5 times every 5 weeks.
Drug: folinate calcium
Other Name: Leucovorin, leucovorinDrug: tegafur-uracil
Other Name: UFT
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660894
|Tokyo Medical and Dental University|
|Tokyo, Japan, 113-8519|
|Principal Investigator:||Kenichi Sugihara, MD, PhD||Tokyo Medical and Dental University|