Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer
Status:
Completed
Trial end date:
2003-05-01
Target enrollment:
Participant gender:
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.