Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid

Date de début de l'étude : 1 mars 1999

DISEASE CHARACTERISTICS: Histologically confirmed stage III adenocarcinoma or mucinous adenocarcinoma of the colon Must have had curative radical resection within 56 days prior to study No local tumor therapy (i.e., polypectomy, local excision or limited intestinal resection) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin greater than 10.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No severe coronary heart disease No New York Heart Association class III or IV heart failure Other: No other malignancy within the past 10 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix No uncontrolled infection No other severe disease No known allergy to leucovorin calcium No known familial adenomatous polyposis, Crohn's disease, or ulcerative colitis No hereditary syndrome (e.g., Gardner's syndrome, Turcot's syndrome, hereditary nonpolyposis colon cancer) Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for colon cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for colon cancer Surgery: See Disease Characteristics Other: No other concurrent systemic anticancer therapy