Home
Search
Study Topics
Glossary
|
|
|
|
|
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 |
Biological: BCG vaccine Biological: biological therapy Drug: fluorouracil Drug: semustine Drug: vincristine sulfate |
Phase III |
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
Study ID Numbers: | CDR0000071312, NSABP-C-01 |
Study First Received: | January 18, 2007 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00427570 History of Changes |
Health Authority: | United States: Federal Government |
stage II colon cancer stage III colon cancer |
Antimetabolites BCG Vaccine Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Colonic Diseases Adjuvants, Immunologic Vincristine Antimitotic Agents Intestinal Diseases Immunosuppressive Agents Rectal Diseases |
Intestinal Neoplasms Digestive System Diseases Fluorouracil Tubulin Modulators Gastrointestinal Neoplasms Semustine Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Colonic Neoplasms Colorectal Neoplasms |
BCG Vaccine Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Rectal Diseases Neoplasms by Site Therapeutic Uses Alkylating Agents Digestive System Neoplasms Mitosis Modulators |
Adjuvants, Immunologic Vincristine Antimitotic Agents Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Tubulin Modulators Gastrointestinal Neoplasms Semustine Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic |