Liver Infusions of Fluorouracil in Treating Patients With Dukes' A, Dukes' B, or Dukes' C Colon Cancer Undergoing Surgery
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, 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 fluorouracil into the liver is more effective than no further treatment for patients with colon cancer undergoing surgery.
PURPOSE: This randomized phase III trial is studying giving infusions of fluorouracil into the liver in treating patients with Dukes' A, Dukes' B, or Dukes' C colon cancer undergoing surgery.
Drug: sodium heparin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Clinical Trial to Evaluate the Postoperative Portal Vein Infusion of 5-Fluorouracil and Heparin in Patients With Resectable Adenocarcinoma of the Colon|
- Disease free interval [ Time Frame: From randomization up to 4 years. ] [ Designated as safety issue: No ]Evidence of treatment failure (presence of tumor in local/regional or distant sites, confirmed by either biopsy or other acceptable evidence.
- Survival [ Time Frame: From randomization up to 4 years. ] [ Designated as safety issue: No ]
|Study Start Date:||March 1984|
|Study Completion Date:||February 2001|
|Primary Completion Date:||September 1989 (Final data collection date for primary outcome measure)|
Experimental: Arm 1: Postoperative 5 FU + sodium heparin
Continuous portal vein infusion with 5 FU 600 mg/m2 + 5000 units sodium heparin per day given for a total of 7 consecutive days.
Other Name: 5 FUDrug: sodium heparin
|Active Comparator: Arm 2: Postoperative observation||Other: Observation|
OBJECTIVES: Determine whether adjuvant therapy with portal hepatic perfusion of 5-fluorouracil and sodium heparin effectively prolongs the disease-free interval and increases survival in patients undergoing curative resection of adenocarcinoma of the colon.
OUTLINE: Randomized study. Patients are randomized preoperatively; those randomized to Arm 1 begin therapy intraoperatively or within 6 hours of colonic resection. Arm 1: 5-Fluorouracil plus sodium heparin. Those randomized to Arm 2 receive no adjuvant therapy. Arm 2: observation (no further treatment).
PROJECTED ACCRUAL: 1,334 patients will be entered over a 4-year period.
|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation, Inc.|