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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Translational Research Informatics Center, Kobe, Hyogo, Japan
• Treatments: Calcium; Calcium, Dietary; Leucovorin; Levoleucovorin; Tegafur

Criteria

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