Liver Infusions of Fluorouracil in Treating Patients With Dukes' A, Dukes' B, or Dukes' C Colon Cancer Undergoing Surgery
|ClinicalTrials.gov Identifier: NCT00427310|
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : January 3, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: fluorouracil Other: Observation Drug: sodium heparin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 1984|
|Actual Primary Completion Date :||September 1989|
|Actual Study Completion Date :||February 2001|
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|
- Disease free interval [ Time Frame: From randomization up to 4 years. ]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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427310
|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|