NCT00290966

Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer

Open Label, Randomized Multicentre Phase II/III Study of Docetaxel in Combination With Cisplatin (CDDP) or Docetaxel in Combination With 5-Fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 610 (planned)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase II: Primary objective: to select one of the 2 test arms (docetaxel with cisplatin, docetaxel with cisplatin and 5-FU), based primarily on complete responses, to advance to a phase III survival comparison against the CDDP + 5-FU control arm. Secondary objective: to evaluate the quantitative and qualitative safety profile of the 2 test groups. Phase III: Primary objective: to detect a statistically significant increase in time to progression (TTP) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU). Main secondary objective: to detect a statistically significant increase in overall survival (OS) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU). Other secondary objectives: to compare response rates, time to treatment failure, duration of response, safety profiles, quality of life and disease-related symptoms.Socio-economic data will be collected in order to be able to perform an analysis by country when necessary.

Conditions

• Stomach Neoplasm

Interventions

Type	Name	Description
DRUG	XRP6976

Timeline

• Start date: 1998-10-01
• Completion: 2003-05-01
• First posted: 2006-02-13
• Last updated: 2009-04-29