Fluorouracil and Leucovorin and/or Levamisole After Surgery In Treating Patients With Dukes’ B Or Dukes’ C Colon Cancer

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Leucovorin may help fluorouracil kill more tumor cells. Biological therapies, such as levamisole, may interfere with the growth of tumor cells and slow the growth of solid tumors. It is not yet known whether fluorouracil is more effective when given together with leucovorin and/or levamisole after surgery in treating colon cancer.
PURPOSE: This randomized phase III trial is studying giving fluorouracil together with leucovorin to see how well it works compared with giving fluorouracil together with levamisole, or giving fluorouracil together with leucovorin and levamisole after surgery in treating patients with Dukes’ B or Dukes’ C colon cancer.

【研究依据】：化疗药物如氟尿嘧啶（fluorouracil）可通过直接杀伤肿瘤细胞或阻断细胞分裂等多种途径抑制肿瘤细胞增殖。亚叶酸（Leucovorin）可增强氟尿嘧啶对肿瘤细胞的杀伤效果。左旋咪唑（levamisole）作为生物治疗药物，可干扰肿瘤细胞生长并延缓实体瘤的增殖。目前尚不清楚，在结肠癌患者的术后治疗中，氟尿嘧啶分别与亚叶酸、左旋咪唑联合，或三者联合给药，是否能提升其治疗有效性。
【研究目的】：本随机III期临床试验旨在针对杜克B期（Dukes’ B）及杜克C期（Dukes’ C）结肠癌患者，评估术后给予氟尿嘧啶联合亚叶酸的治疗效果，并与氟尿嘧啶联合左旋咪唑、以及氟尿嘧啶联合亚叶酸与左旋咪唑的方案进行对比。