Status:
COMPLETED
Liver Infusions of Fluorouracil in Treating Patients With Dukes' A, Dukes' B, or Dukes' C Colon Cancer Undergoing Surgery
Lead Sponsor:
NSABP Foundation Inc
Collaborating Sponsors:
National Cancer Institute (NCI)
Northern California Cancer Center
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 know...
Detailed Description
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 unde...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- more than one synchronous primary colon tumor
- white blood cell (WBC) \> 4000/cu.mm. and platelet count greater than or equal to 100,000/cu.mm.
- 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
Exclusion
Key Trial Info
Start Date :
March 1 1984
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2001
Estimated Enrollment :
1158 Patients enrolled
Trial Details
Trial ID
NCT00427310
Start Date
March 1 1984
End Date
February 1 2001
Last Update
January 3 2013
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