Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: folinate calcium
* Drug: tegafur-uracil
* Drug: tegafur-gimeracil-oteracil potassium


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of colon Stage III (T1-4, N1-3, M0) disease Has undergone surgical resection of the tumor within the past 8 weeks PATIENT CHARACTERISTICS: ECOG performance status 0-1 Able to take medications orally WBC ≥ 3,500/mm³ and < 12,000/mm³ ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 2.0 mg/dL AST/ALT ≤ 100 IU/L Creatinine ≤ 1.2 mg/dL No other active malignancies Must have none of the following comorbidities: Severe postoperative complications Uncontrollable diabetes mellitus Uncontrollable hypertension Myocardial infraction within 6 months Unstable angina pectoris Hepatocirrhosis Interstitial pneumonia, pulmonary fibrosis, or severe emphysema PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for colon cancer No concurrent radiotherapy No concurrent biological response modifiers

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tegafur-gimeracil-oteracil potassium<br>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<br> <br> * Other names: S-1, TS-1;|
| Active Comparator: tegafur-uracil and folinate calcium<br>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<br> <br> * Other names: Leucovorin, leucovorin;Drug: tegafur-uracil<br> <br> * Other names: UFT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Adverse event |  |  | 
| Pharmaco-economics |  |  | 
| Identification of predictive markers |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the colon, stage III colon cancer