Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00290966
Status:
COMPLETED
Last Update Posted:
2009-04-29
First Post:
2006-02-09
Brief Title:
Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Open Label Randomized Multicentre Phase IIIII 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
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 symptomsSocio-economic data will be collected in order to be able to perform an analysis by country when necessary
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 symptomsSocio-economic data will be collected in order to be able to perform an analysis by country when necessary
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| XRP6976E-325 | None | None | None |