Overview

Taxotere New Indication - Gastric Cancer Treatment Registration Trial

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
Primary objective: To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF]) relative to the control group (Cisplatin combined with 5-fluorouracil[CF]) Secondary objectives: - To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group. - To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Treatments:
Cisplatin
Docetaxel
Fluorouracil