Phase II study of temozolomide in metastatic colorectal cancer patients resistant to standard therapies and with O6-methylguanine-DNA methyltransferase (MGMT) promoter hypermethylation

Primary objectives: To assess the antitumor activity in terms of Progression Free Survival (PFS) at 12 weeks since the start of temozolomide in patients with mCRC after failure of at least 2 lines of prior therapy, including fluoropyrimidine-, irinotecan-, oxaliplatin- and, in case of KRAS wild-type, panitumumab- or cetuximab containing therapy
Primary endpoints: PFS rate at 12 weeks, i.e. the proportion of patients known to be alive and progression free at 12 weeks or later since treatment start. The primary efficacy analysis will be performed on the proportion of treated patients in a progression free-status at 12 weeks.

主要研究目标：针对经至少2线既往治疗失败的转移性结直肠癌（metastatic colorectal cancer, mCRC）患者，评估替莫唑胺（temozolomide）治疗启动后12周的无进展生存期（Progression Free Survival, PFS）相关抗肿瘤活性；其既往治疗方案包括含氟嘧啶（fluoropyrimidine）、伊立替康（irinotecan）、奥沙利铂（oxaliplatin）的治疗方案，以及针对KRAS野生型（KRAS wild-type）患者的含帕尼单抗（panitumumab）或西妥昔单抗（cetuximab）的治疗方案。
主要终点：12周无进展生存期率，即治疗开始后12周及更晚时间点仍存活且无疾病进展的患者占比。主要疗效分析将基于治疗启动后12周时处于无进展状态的经治患者比例开展。