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Trial record 41 of 722 for:    colon cancer AND 5-FU

Liver Infusions of Fluorouracil in Treating Patients With Dukes' A, Dukes' B, or Dukes' C Colon Cancer Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00427310
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : January 3, 2013
National Cancer Institute (NCI)
Northern California Cancer Center
Information provided by (Responsible Party):
NSABP Foundation Inc

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 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

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
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.
Drug: fluorouracil
Other Name: 5 FU

Drug: sodium heparin
Active Comparator: Arm 2: Postoperative observation Other: Observation

Primary Outcome Measures :
  1. 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.

  2. Survival [ Time Frame: From randomization up to 4 years. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • more than one synchronous primary colon tumor
  • white blood cell (WBC) > 4000/ and platelet count greater than or equal to 100,000/
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00427310

Sponsors and Collaborators
NSABP Foundation Inc
National Cancer Institute (NCI)
Northern California Cancer Center
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Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc

Publications of Results:
Wolmark N, Rockette H, Petrelli N, et al.: Long-term results of the efficacy of perioperative portal vein infusion of 5-FU for treatment of colon cancer: NSABP C-02. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-561, 194, 1994.

Other Publications:
Kim GP, Colangelo L, Wieand H, et al.: Prognostic and predictive roles of high-degree microsatellite instability (MSI-H) in colon cancer: National Cancer Institute (NCI)-National Surgical Adjuvant Bowel Project (NSABP) collaborative study. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-227, 2005.

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Responsible Party: NSABP Foundation Inc Identifier: NCT00427310     History of Changes
Other Study ID Numbers: NSABP C-02
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: December 2012
Keywords provided by NSABP Foundation Inc:
stage I colon cancer
stage II colon cancer
stage III colon cancer
adenocarcinoma of the colon
Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Calcium heparin
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents