Liver Infusions of Fluorouracil in Treating Patients With Dukes' A, Dukes' B, or Dukes' C Colon Cancer Undergoing Surgery
This study has been completed.
Sponsor:
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Collaborators:
Northern California Cancer Center
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT00427310
First received: January 18, 2007
Last updated: December 31, 2012
Last verified: December 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: fluorouracil Other: Observation Drug: sodium heparin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
Primary Outcome Measures:
- Disease free interval [ Time Frame: From randomization up to 4 years. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]
| Enrollment: | 1158 |
| Study Start Date: | March 1984 |
| Study Completion Date: | February 2001 |
| Primary Completion Date: | September 1989 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
Publications:
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.
Wilkinson NW, Yothers G, Lopa SH, et al.: Long-term survival results of surgery alone compared with surgery plus 5-fluorouracil and leucovorin for stage II and stage III colon cancer: pooled analysis of NSABP adjuvant trials C-01 through C-05. [Abstract] American Society of Clinical Oncology 2009 Gastrointestinal Cancers Symposium, 15-17 January 2009, San Francisco, CA. A-442, 2009.
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.
| Responsible Party: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| ClinicalTrials.gov Identifier: | NCT00427310 History of Changes |
| Other Study ID Numbers: | NSABP C-02 |
| Study First Received: | January 18, 2007 |
| Last Updated: | December 31, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
|
stage I colon cancer stage II colon cancer stage III colon cancer adenocarcinoma of the colon |
Additional relevant MeSH terms:
|
Adenocarcinoma Colonic Neoplasms Colorectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Fluorouracil Calcium heparin Heparin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anticoagulants Hematologic Agents |
ClinicalTrials.gov processed this record on June 18, 2013