A Clinical Trial to Evaluate the Postoperative Portal Vein Infusion of 5-Fluorouracil and Heparin in Patients With Resectable Adenocarcinoma of the Colon
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free interval
Evidence of treatment failure (presence of tumor in local/regional or distant sites, confirmed by either biopsy or other acceptable evidence.
From randomization up to 4 years.
Norman Wolmark, MD
NSABP Foundation, Inc.
United States: Federal Government