Colorectal Cancer Clinical Trial
Official title:
A Clinical Trial to Evaluate Postoperative Immunotherapy and Postoperative Systemic Chemotherapy in the Management of Resectable Colon Cancer
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.
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.
;
Primary Purpose: Treatment
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