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
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
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:
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Biological samples are collected for gene expression analysis for identification of predictive markers.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of colon
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:
PRIOR CONCURRENT THERAPY: