Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT00660894|
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : August 3, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: folinate calcium Drug: tegafur-uracil Drug: tegafur-gimeracil-oteracil potassium||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1535 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||July 2015|
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, leucovorin
Other Name: UFT
- Disease-free survival
- Overall survival
- Adverse event
- Identification of predictive markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660894
|Tokyo Medical and Dental University|
|Tokyo, Japan, 113-8519|
|Principal Investigator:||Kenichi Sugihara, MD, PhD||Tokyo Medical and Dental University|