Department of Colorectal Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.
Department Of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
BMJ Open. 2019 Jan 29;9(1):e017637. doi: 10.1136/bmjopen-2017-017637.
Adjuvant chemotherapy with the CapeOX regimen is now widely used for treating colorectal cancer. However, prior studies have demonstrated better efficacy of pre-operative/neoadjuvant chemotherapy without increase of safety risks.
This multicentre, open-label, parallel-group, randomised, controlled, phase III study aims to compare the efficacy and safety of perioperative CapeOX chemotherapy with the postoperative one for treating patients with locally advanced R0 resectable colon cancers in China. In total 1370 eligible patients will be randomised to: the test group, up to four cycles (every 3 weeks is a cycle, Q3W) of chemotherapy plus radical surgery plus up to four cycles of post-operative chemotherapy; or the control group, radical surgery first, then up to eight cycles of chemotherapy. In each cycle, oxaliplatin will be given at a dose of 130 mg/m through continuous IV infusion for 2 hours on the first day. From day 1 to day 14, capecitabine will be taken orally every morning and evening at a dose of 1000mg/m/d. The primary outcome measure is the 3-year disease free survival. The objective response rate, R0 resection rate, overall survival, as well as the adverse events will also be measured as second endpoints. The study may include two periods. If results of period 1 are not favourable, period 2 will be initiated, recruiting genetically sensitive patients and repeating the same process with period 1.
Informed consent will be required from, and provided, by all subjects. The study protocol has been approved by the independent ethics committee of Shanghai Fudan University Cancer Centre. This study will clearly demonstrate the potential benefit of perioperative chemotherapy with the CapeOX regimen. Results will be shared among all the participating centres, and with policymakers and the academic community to promote the clinical management of colon cancer.
NCT03125980.
卡培他滨奥沙利铂（CapeOX）辅助化疗目前被广泛用于治疗结直肠癌。然而，先前的研究表明，术前/新辅助化疗的疗效更好，且没有增加安全风险。
这是一项多中心、开放标签、平行组、随机、对照、III 期研究，旨在比较围手术期 CapeOX 化疗与术后化疗治疗中国局部晚期可切除 R0 结肠癌患者的疗效和安全性。共有 1370 名合格患者将被随机分为：试验组，最多进行四个周期（每 3 周为一个周期，Q3W）的化疗加根治性手术加最多四个周期的术后化疗；或对照组，首先进行根治性手术，然后进行最多 8 个周期的化疗。在每个周期中，奥沙利铂的剂量为 130mg/m，通过连续静脉输注 2 小时，第 1 天给予。从第 1 天到第 14 天，卡培他滨每天早晚口服，剂量为 1000mg/m/d。主要终点是 3 年无病生存率。客观缓解率、R0 切除率、总生存率以及不良反应也将作为次要终点进行测量。该研究可能包括两个阶段。如果第 1 阶段的结果不理想，将启动第 2 阶段，招募遗传敏感患者，并重复第 1 阶段的相同过程。
所有受试者均需获得并提供知情同意。该研究方案已获得上海复旦大学肿瘤中心独立伦理委员会的批准。本研究将清楚地证明围手术期 CapeOX 方案化疗的潜在益处。结果将在所有参与中心、政策制定者和学术界共享，以促进结直肠癌的临床管理。
NCT03125980。
