The MAX study: A randomised phase II/III study to evaluate the role of Mitomycin C, Avastin and Xeloda in patients with untreated metastatic colorectal cancer

Primary objectives: Phase II stagePrimary Objective:• To determine the relative toxicity of the combination of capecitabine andbevacizumab and the combination of capecitabine, mitomycin C (MMC) andbevacizumab with that of capecitabine monotherapy.
Phase III stagePrimary Objective:• To compare progression-free survival (PFS) on the three arms
Primary endpoints: Phase II stagePrimary Endpoint: Treatment-related toxicity
Phase III stagePrimary endpoint: Progression free survival (PFS)

研究目标：
II期阶段主要目标：
• 明确卡培他滨（capecitabine）联合贝伐珠单抗（bevacizumab）、卡培他滨联合丝裂霉素C（mitomycin C, MMC）联合贝伐珠单抗与卡培他滨单药治疗的相对毒性。
III期阶段主要目标：
• 对比三个试验组的无进展生存期（progression-free survival, PFS）。

主要终点：
II期阶段主要终点：治疗相关毒性（treatment-related toxicity）
III期阶段主要终点：无进展生存期（progression-free survival, PFS）