drugset / Trial / NCT00770874

Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer

NCT00770874

Phase 3 Completed 375 enrolled Taiho Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is an open-label, multicenter, multinational, two-arm, parallel randomized Phase 3 study evaluating the efficacy and safety of S-1+Cisplatin versus single-agent Cisplatin in patients with stage IVB, recurrent or persistent carcinoma of the cervix.

Timeline

Start
2008-09
Primary completion
2015-12
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject S-1 Small molecule 80 mg Oral
Subject S-1 Small molecule 120 mg Oral
Comparator Cisplatin Other / unclassified 50 mg/m2 Intravenous

Indications