Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195572
Status:
COMPLETED
Last Update Posted:
2009-08-13
First Post:
2005-09-12
Brief Title:
Study Evaluating Isovorin in AdvancedRecurrent Gastric Cancer
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
Post-Approved Phase III Study of 1-LV5FU Therapy
Status:
COMPLETED
Status Verified Date:
2009-08
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:
The purpose of the study is to verify non-inferiority of survival time between Isovorin5-fluorouracil 1-LV5FU therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer Secondary endpoints include response rates duration of responses time to progression TTP safety and quality of life QOL
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