Know Cancer

forgot password

A Clinical Trial to Evaluate the Postoperative Portal Vein Infusion of 5-Fluorouracil and Heparin in Patients With Resectable Adenocarcinoma of the Colon

Phase 3
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

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.

Inclusion Criteria:

- more than one synchronous primary colon tumor

- white blood cell (WBC) > 4000/ and platelet count greater than or equal to

- evidence of adequate renal (serum creatinine less than or equal to 1.5 mg%) and
hepatic function (bilirubin less than or equal to 1.5 mg%; serum glutamic oxaloacetic
transaminase (SGOT) less than or equal to 60 I.U./ml)

- performance status of 0, 1 or 2

- Patients with intestinal obstruction are eligible. Preliminary or complementary
colostomy does not preclude entry of a patient provided randomization is carried out
prior to the planned curative resection.

- The distal margin of the tumor must be greater than or equal to 12 cm from the anal
verge as endoscopically measured with the patient in the knee-chest position.

- Carcinoembryonic antigen (CEA) must be performed pre-operatively but results need not
be known at the time of randomization.

Exclusion criteria:

- malignant colon tumors other than carcinoma, i.e., sarcoma, lymphoma, etc.

- patients whose tumors demonstrate free perforation

- previous or concomitant malignancy, regardless of site - except patients with
squamous or basal cell carcinoma of the skin, and carcinoma in situ of the cervix
which have been adequately treated

- patients who have received prior treatment other than preliminary or complementary
colostomy (radiation, chemotherapy or surgery) for their current malignancy.

- patients having tumors within 12 cm of the anal verge

- performance status of 3 or 4

- patients having non-malignant systemic disease (cardiovascular, renal, hepatic, etc.)
which would preclude their being subject to the chemotherapy treatment option

- patients who are pregnant at the time of randomization

- patients with psychiatric or addictive disorders which would preclude obtaining
informed consent

- patients who have multiple primary tumors involving both the colon and the rectum
which would preclude them from being classified as having only colon cancer or only
rectal cancer

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free interval

Outcome Description:

Evidence of treatment failure (presence of tumor in local/regional or distant sites, confirmed by either biopsy or other acceptable evidence.

Outcome Time Frame:

From randomization up to 4 years.

Safety Issue:


Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.


United States: Federal Government

Study ID:




Start Date:

March 1984

Completion Date:

February 2001

Related Keywords:

  • Colorectal Cancer
  • stage I colon cancer
  • stage II colon cancer
  • stage III colon cancer
  • adenocarcinoma of the colon
  • Adenocarcinoma
  • Colonic Neoplasms
  • Colorectal Neoplasms