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Fluorouracil, Semustine, and Vincristine Compared With BCG in Treating Patients With Dukes' B or Dukes' C Colon Cancer That Has Been Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00427570
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as vincristine, fluorouracil, and semustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as BCG, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether combination chemotherapy is more effective than BCG in treating colon cancer that has been removed by surgery.

PURPOSE: This randomized phase III clinical trial is studying giving fluorouracil together with semustine and vincristine to see how well they work compared with giving BCG in treating patients with Dukes' B or Dukes' C colon cancer that has been removed by surgery.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: BCG vaccine Biological: biological therapy Drug: fluorouracil Drug: semustine Drug: vincristine sulfate Phase 3

Detailed Description:

OBJECTIVES: I. Obtain information to define subsets of colon cancer patients at high risk of recurrence. II. Correlate pathologic and biologic parameters with disease-free interval and survival. III. Determine the value of surgical and ancillary techniques in management of colon cancer. IV. Compare disease-free interval and survival after curative resection vs. chemotherapy with 5-fluorouracil/methyl-CCNU/vincristine vs. BCG immunotherapy. V. Relate the total lymphocyte count to the course of the disease. VI. Determine the feasibility of conducting a trial employing immunotherapy in a surgical adjuvant setting. VII. Identify appropriate future protocols based on data generated in the study.

OUTLINE: Randomized study for patients with Dukes Stage B and C disease only. All patients with Dukes A and D lesions enter Arm I. Arm I: No therapy following surgery. Arm II: 3-Drug Combination Chemotherapy. 5-Fluorouracil, 5-FU, NSC-19893; Methyl-CCNU, MeCCNU, NSC-95441; Vincristine, VCR, NSC-67574. Arm III: Immunotherapy. BCG-Pasteur, BCG, NSC-B116328.

PROJECTED ACCRUAL: Protocol closed February 1984.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Clinical Trial to Evaluate Postoperative Immunotherapy and Postoperative Systemic Chemotherapy in the Management of Resectable Colon Cancer
Study Start Date : September 1977
Actual Study Completion Date : May 2006




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Ages Eligible for Study:   up to 79 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria


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 ClinicalTrials.gov identifier (NCT number): NCT00427570


Sponsors and Collaborators
NSABP Foundation Inc
National Cancer Institute (NCI)
Investigators
Study Chair: Norman Wolmark, MD Allegheny Cancer Center at Allegheny General Hospital

Publications of Results:
Wolmark N, Fisher B, Rockette H, et al.: Adjuvant therapy in carcinoma of the colon: five year results of NSABP protocol C-01. [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-358, 92, 1987.
Weese JL, Starling JR, Ottery FD, et al.: Should omentectomy be part of colectomy for colon cancer? [Abstract] Proceedings of the American Society of Clinical Oncology 4: C-358, 92, 1985.

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.

ClinicalTrials.gov Identifier: NCT00427570     History of Changes
Other Study ID Numbers: CDR0000071312
NSABP-C-01
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: August 2010

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage III colon cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Vincristine
Semustine
BCG Vaccine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Adjuvants, Immunologic
Antineoplastic Agents, Alkylating
Alkylating Agents