Trial Information

A Clinical Trial to Evaluate Postoperative Immunotherapy and Postoperative Systemic Chemotherapy in the Management of Resectable Colon Cancer

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.