Trials / Completed
CompletedNCT00660894
Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,535 (actual)
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | folinate calcium | |
| DRUG | tegafur-uracil | |
| DRUG | tegafur-gimeracil-oteracil potassium |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2012-06-01
- Completion
- 2015-07-01
- First posted
- 2008-04-17
- Last updated
- 2016-08-03
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00660894. Inclusion in this directory is not an endorsement.