肉瘤化疗SUCCEEDASCO2011解决方案.ppt

The primary endpoint of the study is Progression Free Survival by central review. The secondary endpoints were : Survival, best target lesion response, cancer related symptoms, and safety and tolerability. The study is designed to have 90% power, which would take 516 PFS events to detect a 33% improvement, with one side alpha rate of .025 Results were stratified for line of therapy, histology, and geographic region 711 pts were enrolled in less than 2 and a half years. Of the 711 patients enrolled, 364 patients were in the placebo arm, and 347 patients were in the rida arm. Al