Fluorouracil and Oxaliplatin With or Without Panitumumab In Treating Patients With High-Risk Colon Cancer That Can Be Removed by Surgery

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective with or without panitumumab in treating patients with colon cancer.
PURPOSE: This randomized phase III trial assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody improve outcome in high risk operable colon cancer.

研究依据：氟尿嘧啶（fluorouracil）、奥沙利铂（oxaliplatin）等化疗药物可通过多种途径阻断肿瘤细胞增殖，具体机制包括直接杀伤肿瘤细胞或抑制其分裂。帕尼单抗（panitumumab）等单克隆抗体（monoclonal antibody）亦可通过多种途径抑制肿瘤生长：部分单克隆抗体可阻断肿瘤细胞增殖与扩散的能力，另有部分可靶向结合肿瘤细胞，协助杀伤肿瘤细胞或将抗肿瘤物质递送至肿瘤部位。术前化疗可缩小肿瘤体积，减少需切除的正常组织范围；术后化疗则可清除术后残留的肿瘤细胞。目前尚不明确在结肠癌治疗中，联合帕尼单抗的化疗方案是否优于单纯化疗方案。
试验目的：本项随机对照III期临床试验旨在评估术前化疗联合或不联合抗EGFR（Epidermal Growth Factor Receptor）单克隆抗体，能否改善高危可切除结肠癌患者的临床预后。