AGC化疗研究生讲课.pptVIP

* ML17032 trial design – An open label, randomized, international multi-center Phase III study of Xeloda in combination with cisplatin versus 5-FU/cisplatin. The doses evaluated were: Cisplatin: 80mg/m2 3- hour i.v. infusion on d1 with hyperhydration Xeloda: 1 000mg/m2 daily; d1-14 q3 weeks 5-FU: 800mg/m2/day; d1-5 q3 weeks. A total of 316 patients were enrolled: 160 randomized to Xeloda/cisplatin and 156 randomized to 5-FU/cisplatin. The target population was typical for a first-line trial with creatinine clearance 60mL/min and measurable disease according to RECIST criteria. Primary objectiv