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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1,535 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,535

Conditions

Colorectal Cancer

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes