Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202969
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2005-09-12
Brief Title:
Study of S-1 S-1CDDP and 5-FUCDDP for Advanced Gastric Cancer
Sponsor:
Taiho Pharmaceutical Co Ltd
Organization:
Taiho Pharmaceutical Co Ltd
Study Overview
Official Title:
An Open-label Multicenter Randomized 3 Arm Study of S-1 Compared With S-1CDDP or S-1CDDP Compared With 5-FUCDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Status:
COMPLETED
Status Verified Date:
2011-07
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:
This is an open-label multicenter three arm parallel randomized Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease Patients will be randomly assigned 111 to S-1 Arm A S-1CDDP Arm B or 5-FUCDDP Arm C Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications performance status 0 1 or 2 the number of metastatic sites 1 vs 1 prior gastrectomy and center
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