A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FU/LV Combination in First-Line Treatment of Patients With Metastatic Colorectal Carcinoma(MCRC)

Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo group ; Compare the response rate between treatment group and placebo group.Secondary objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free survival, overall survival) ; safety profile.

本试验旨在评估沙利丙多（Xaliproden）在转移性结直肠癌患者中减轻奥沙利铂联合5-FU/LV化疗所致神经毒性的疗效。主要研究终点：比较治疗组与安慰剂组中3~4级周围感觉神经病的发生风险与奥沙利铂累积剂量的相关性；比较两组的缓解率。次要研究终点：神经毒性相关参数（总体发生率、发病时间与对应累积剂量、恢复时间、感觉动作电位变化）；抗肿瘤疗效（无进展生存期、总生存期）；安全性概况。