Ignite Creation Date:
2024-05-05 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00639327
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2008-03-05
Brief Title:
Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
Sponsor:
Japan Clinical Cancer Research Organization
Organization:
Japan Clinical Cancer Research Organization
Study Overview
Official Title:
Randomized Phase IIIII Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1CPT-11 Combination for S-1 Refractory Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2011-06
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 this study is compare overall survival of the test arm CPT-11S-1 combination to the control arm CPT-11 alone in the subjects with S-1 refractory advanced gastric cancer
Detailed Description:
Standard chemotherapy for advanced gastric cancer AGC in the US is Cisplatin5-FU CF or docetaxelCF DCF is in Europe epirubicinCF ECF or epirubicinoxaliplatin capecitabine EOX Until 2006 there was no evidence of standard chemotherapy for AGC in Japan In 2007 by the results of JCOG9912 trial 5-FU alone vs CPT-11CDDP vs S-1 and SPIRITS trial S-1 alone vs S-1CDDP S-1CDDP is regarded as a new standard regimen in Japan In 2008 by the results of TOP-002 trial s-1 alone vs S-1CPT-11 S-1CPT-11 could not show the superiority to S-1 alone One of the other phase III trials JACCRO GC-03 trial S-1 alone vs S-1docetaxel NCT00287768 is now ongoing However the position of CPT-11 in the treatment of AGC will be regarded as a second-line
In Japan there is a controversy for the treatment of S-1 refractory gastric cancer The controversy is continuing S-1 like FOLFOX to FOLFIRI or not as a second-line After the successful adjuvant S-1 results ACTS-GC trial the same problem will occur in the patients who are recurrent from adjuvant S-1
Then we conducted a phase IIIII trial of CPT-11 with or without S-1 in the treatment of first-line S-1 refractory AGC
In Japan there is a controversy for the treatment of S-1 refractory gastric cancer The controversy is continuing S-1 like FOLFOX to FOLFIRI or not as a second-line After the successful adjuvant S-1 results ACTS-GC trial the same problem will occur in the patients who are recurrent from adjuvant S-1
Then we conducted a phase IIIII trial of CPT-11 with or without S-1 in the treatment of first-line S-1 refractory AGC
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