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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00427570 |
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 | Intervention | Phase |
Colorectal Cancer |
Drug: BCG vaccine Drug: fluorouracil Drug: semustine Drug: vincristine sulfate Procedure: biological therapy |
Phase III |
MedlinePlus related topics: | Cancer Colorectal Cancer |
ChemIDplus related topics: | Vincristine sulfate Vincristine Fluorouracil BCG Vaccine Semustine |
Study Type: | Interventional |
Study Design: | 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 |
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.
Ages Eligible for Study: | up to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
National Surgical Adjuvant Breast and Bowel Project (NSABP) |
National Cancer Institute (NCI) |
Study Chair: | Norman Wolmark, MD | Allegheny Cancer Center at Allegheny General Hospital |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Smith RE, Colangelo L, Wieand HS, Begovic M, Wolmark N. Randomized trial of adjuvant therapy in colon carcinoma: 10-year results of NSABP protocol C-01. J Natl Cancer Inst. 2004 Aug 4;96(15):1128-32.
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Wolmark N, Fisher B, Rockette H, Redmond C, Wickerham DL, Fisher ER, Jones J, Glass A, Lerner H, Lawrence W, et al. Postoperative adjuvant chemotherapy or BCG for colon cancer: results from NSABP protocol C-01. J Natl Cancer Inst. 1988 Mar 2;80(1):30-6.
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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.
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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.
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Study ID Numbers: | CDR0000071312, NSABP-C-01 |
First Received: | January 18, 2007 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00427570 |
Health Authority: | United States: Federal Government |
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