Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-03-06 @ 12:59 AM
Study NCT ID:
NCT00580359
Status:
UNKNOWN
Last Update Posted:
2008-01-08
First Post:
2007-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-1 vs Capecitabine in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer
Sponsor:
National Cancer Center, Korea
Organization:
Study Overview
Official Title:
A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2007-12
Last Known Status:
RECRUITING
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 study is an open-label, single-center, and randomized phase II study designed to evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer. The randomization will be stratified by age (70-85 years versus 65 years and \< 70 years) and performance status, which is dependent on age group; in 70-85 years, ECOG performance status 0-1 versus 2 and in ³65 years and \<70 years, ECOG performance status 2 versus 3.
* S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
* Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Treatment will be administered every 3 weeks and will be continued in the absence of disease progression or unacceptable toxicity.
* S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
* Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Treatment will be administered every 3 weeks and will be continued in the absence of disease progression or unacceptable toxicity.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: