Spots Global Cancer Trial Database for Taxotere New Indication - Gastric Cancer Treatment Registration Trial
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Trial Identification
Brief Title: Taxotere New Indication - Gastric Cancer Treatment Registration Trial
Official Title: Open Label, Randomized Multicenter Study Docetaxel + 5-fluorouracil + Cisplatin Compared to Cisplatin + 5-fluorouracil in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Study ID: NCT00811447
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sanofi-Aventis Administrative Office, Shanghai, , China
Contact Details
Name: Martin Thoenes
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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