Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed

Launched by ECOG-ACRIN CANCER RESEARCH GROUP · Apr 5, 2004

Keywords

ClinConnect Summary

OBJECTIVES:

I. To determine if adjuvant therapy with one week of continuous 5-FU given within 24 hours of a curative colon resection followed by 6 months of 5-FU/leucovorin is effective in prolonging the disease-free survival and increasing overall survival in patients with Dukes' B3 or C colon cancer, when compared to patients who are treated with 5-FU/leucovorin only.

II. 1. To determine if a week of perioperative continuous 5-FU affects disease-free survival and overall survival in patients with Dukes' B2 colon cancer.

OUTLINE: This is an open-label, randomized phase III study. Patien...

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Eligibility criteria

• 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).