Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514163
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2007-08-08
Brief Title:
GEM vs GEMTS-1 for Advanced Pancreatic Cancer
Sponsor:
Japan Clinical Cancer Research Organization
Organization:
Japan Clinical Cancer Research Organization
Study Overview
Official Title:
Randomized Phase II Study of Gemcitabine GEM Versus GEMTS-1 for Advanced Pancreatic 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 tumor response rate of the test armgemcitabineS-1 with the control armgemcitabine alone in patients with unresectable pancreatic cancer
Detailed Description:
Pancreatic cancer is the fifth leading cause of cancer death in the United States It is difficult to diagnose at its early stage and only 10-20 of patients are candidates for resection with 5-year survival rate of less than 10 Patients with unresectable pancreatic cancer has a poor prognosis Gemcitabine a cytidine analogue is the standard chemotherapeutic agent for the disease with median survival timeMST ranging from 6 to 8 months Phase Ⅲ study showed that combinations with other drugs such as oxaliplatine or CDDP did not contribute to survival time TS-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 was effective as a single agent for treatment of gastric RR 446 colorectal RR 374 head and neck breast non-small cell lung and pancreatic cancers20 A combination of gemcitabine and TS-1 is found to be effective and promising in phase Ⅱ trial for metastatic pancreatic carcinoma in selected subjects but the combination therapy has high rate of side effects This phase Ⅱ randomized controlled study compares efficacy and feasibility of GEMS-1 with GEM alone in patients with locally advanced and metastatic pancreatic cancer and performance status of 0-2 aiming at patients in rather ordinary clinical settings
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