Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152217
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2005-09-08
Brief Title:
Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer ACTS-GC
Sponsor:
Taiho Pharmaceutical Co Ltd
Organization:
Taiho Pharmaceutical Co Ltd
Study Overview
Official Title:
Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer ACTS-GC
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 controlled study is designed to evaluate the efficacy of TS-1 on survival compared with surgery alone Patients will be randomly assigned to receive either surgery alone or surgery followed by treatment with TS-1 within 45 days after curative resection curability A or B To assess the efficacy data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery To evaluate safety data on adverse events will be collected from the time of enrollment until 1 year after surgery
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