NCT00811447

Taxotere New Indication - Gastric Cancer Treatment Registration Trial

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	5-fluorouracil	600 mg/m²/day intravenous
DRUG	Cisplatin	60 mg/m² or 75 mg/m² intravenous
DRUG	Docetaxel	60 mg/m² intravenous

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2008-12-19
• Last updated: 2012-08-31

Locations

1 site across 1 country: China