Colorectal Cancer Clinical Trial
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
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.
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
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