Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287768
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2006-02-03
Brief Title:
Phase III Study of Docetaxel S-1 vs S-1 for Advanced Gastric Cancer
Sponsor:
Japan Clinical Cancer Research Organization
Organization:
Japan Clinical Cancer Research Organization
Study Overview
Official Title:
A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced 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 primary objective of this study is to compare median overall survival of the test arm docetaxel and S-1 to the control arm S-1 only in subjects with advanced or recurrent gastric cancer
Detailed Description:
Seven-hundred and fifty thousand of new gastric cancer cases are diagnosed worldwide per year Advanced gastric cancer AGC is considered nearly incurable with less than 10 of subjects alive 5 years after diagnosis Therefore new treatment regimens are needed for subjects with AGC
S-1 a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur ftorafur FT and two enzyme inhibitors CDHP 5-chloro-24-dihydroxypyridine and OXO potassium oxonate in a molar ratio of 1FT04 CDHP1OXO is commercially available since late 90in Japan Phase II trials have demonstrated that S-1 is active as a single agent for the treatment of gastric RR 446 colorectal RR 374 head and neck breast non-small cell lung and pancreatic cancers In gastric cancer phase III trials JCOG 9912 comparing 5-FU alone and CPT-11CDDP combination are currently underway and these results are awaited Despite of JCOG 9912 study is ongoing 80 of patients of AGC are already treated by S-1 because of high RR and convenience use for out-patient basis P-II studies S-1CDDP S-1CPT-11 and S-1Docetaxel showed high RR55-76 and long MST12-14M Furthermore P-III studies are already conducted S-1 vs S-1CDDP and S-1 vs S-1CPT-11 in Japan The aim of this study is to compare S-1Docetaxel vs S-1 alone in the patients of AGC This study is a prospective multicenter multinational non-blinded randomized phase III study
Patients Inoperable or relapse gastric cancer Informed consent must be obtained in writing before treatment Subjects meeting all of the inclusion criteria and exclusion criteria will be considered for enrollment into study Then patients will be randomly assigned into two groups S-1DocetaxelTreatment Arm A or S-1 aloneTreatment Arm B
S-1 a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur ftorafur FT and two enzyme inhibitors CDHP 5-chloro-24-dihydroxypyridine and OXO potassium oxonate in a molar ratio of 1FT04 CDHP1OXO is commercially available since late 90in Japan Phase II trials have demonstrated that S-1 is active as a single agent for the treatment of gastric RR 446 colorectal RR 374 head and neck breast non-small cell lung and pancreatic cancers In gastric cancer phase III trials JCOG 9912 comparing 5-FU alone and CPT-11CDDP combination are currently underway and these results are awaited Despite of JCOG 9912 study is ongoing 80 of patients of AGC are already treated by S-1 because of high RR and convenience use for out-patient basis P-II studies S-1CDDP S-1CPT-11 and S-1Docetaxel showed high RR55-76 and long MST12-14M Furthermore P-III studies are already conducted S-1 vs S-1CDDP and S-1 vs S-1CPT-11 in Japan The aim of this study is to compare S-1Docetaxel vs S-1 alone in the patients of AGC This study is a prospective multicenter multinational non-blinded randomized phase III study
Patients Inoperable or relapse gastric cancer Informed consent must be obtained in writing before treatment Subjects meeting all of the inclusion criteria and exclusion criteria will be considered for enrollment into study Then patients will be randomly assigned into two groups S-1DocetaxelTreatment Arm A or S-1 aloneTreatment Arm B
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