A Clinical Trial to Evaluate Postoperative Immunotherapy and Postoperative Systemic Chemotherapy in the Management of Resectable Colon Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS: See General Eligibility Criteria
- •PATIENT CHARACTERISTICS: See General Eligibility Criteria
排除标准
- 未提供