Perioperative 5-FU and 5-FU/Leucovorin for Dukes' B3 or C Colon Cancer

Study start date: October 1, 1993

Eligibility Criteria for Randomization: Inclusion Criteria: Adenocarcinoma of the colon documented by colonoscopy or barium enema Tumor either considered resectable or totally resected within 24 hours prior to study Randomization within 2 weeks prior to surgery or within 24 hours after surgery required Patients randomized after surgery must meet the following criteria: Complete resection performed with no evidence of residual disease or distant metastases Distal margin of tumor above the peritoneal reflection in area of rectum No free perforation Intestinal obstruction allowed Preliminary or complementary colostomy allowed Concurrent registration for E3293 strongly recommended Age 18 and over Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate organ function based on the following tests within 2 weeks prior to randomization White Blood Cell (WBC) at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 2.0 mg/dL Creatinine no greater than 2.0 mg/dL No second malignancy within 5 years except: superficial non-melanomatous skin cancer and carcinoma in situ of the cervix Fertile patients must use adequate contraception Exclusion Criteria: Dual primary tumors Prior nonmalignant systemic disease that would preclude use of chemotherapy Pregnant or nursing Prior fluorouracil Other prior or concurrent chemotherapy for this malignancy Prior or concurrent radiotherapy for this malignancy Eligibility Criteria for Re-registration for Patients Randomized Pre-operatively: Must have pathologic classification of Dukes' B2, B3, or C disease by the contributing institution. Must be re-registered < 35 days after surgery. ECOG performance status of 0-2. Complete resection must have been performed with no evidence of residual disease or distant metastasis. Distal margin of the tumor must not extend below the peritoneal reflection in the area of the rectum. Single primary colon carcinoma without free perforation demonstrated. Patients with intestinal obstruction are eligible. Preliminary or complementary colostomy dose not preclude entry of a patient. Have WBC > 3000/mm^3, platelets > 100,000/mm^3, adequate renal (serum creatinine <= 2.0mg/dL) and hepatic function (bilirubin <= 2.0mg/dL), within one week prior to beginning adjuvant chemotherapy (For Dukes' B3 and C patients only). Eligibility Criteria for Re-registration for Patients Randomized Post-operatively: Must have pathologic classification of Dukes' B2, B3, or C disease by the contributing institution. Patient must be re-registered < 35 days after surgery. ECOG performance status of 0-2. Started perioperative 5-FU, if assigned, within 24 hours of surgery. Have WBC > 3000/mm^3, platelets > 100,000/mm^3, adequate renal (serum creatinine <= 2.0mg/dL) and hepatic function (bilirubin < =2.0mg/dL), within one week prior to beginning adjuvant chemotherapy (For Dukes' B3 and C patients only).