Stomach Neoplasm Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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