Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152243
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2005-09-08
Brief Title:
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur UFT Compared With Surgery Alone NSAS-GC
Sponsor:
Taiho Pharmaceutical Co Ltd
Organization:
Taiho Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer NSAS-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 is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection To assess treatment response data on recurrence and survival will be collected for 5 years after enrollment of the last patient To evaluate safety data on adverse events will be collected for 16 months after the start of treatment
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