drugset / Trial / NCT01285557

Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

NCT01285557

Phase 3 Terminated 361 enrolled Taiho Oncology, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.

Timeline

Start
2011-04-14
Primary completion
2014-08-15
Completion
2014-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 80 mg/m2 Intravenous
Subject S-1 Small molecule 25 mg/m2 Oral
Comparator fluorouracil Small molecule 800 mg/m2 Intravenous