Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503321
Status:
TERMINATED
Last Update Posted:
2009-01-23
First Post:
2007-07-16
Brief Title:
Phase II Study of TS-1 Therapy and TS-1PSK Therapy Against Advanced Gastric Carcinoma
Sponsor:
Eastern Network of Cancer Immunological Therapy Japan
Organization:
Eastern Network of Cancer Immunological Therapy Japan
Study Overview
Official Title:
Randomized Phase II Study of TS-1 Therapy and TS-1PSK Therapy Against Unresectable Advanced Gastric Carcinoma and Recurrent Gastric Carcinoma
Status:
TERMINATED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Patients enrollment was not sufficient
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eNCIT-Japan
Brief Summary:
A randomized controlled study is conducted on unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1 PSK therapy The primary endpoint of this study is progression-free survival PFS with secondary endpoints of anticancer effect time to treatment failure TTF QOL FACT-BRM compliance adverse drug reactions and immunological factors
Detailed Description:
Tegafur gimeracil oteracil potassium TS-1 is widely used as a first-line drug for unresectable advanced gastric carcinoma and recurrent gastric carcinoma in Japan and the response rate of TS-1 against gastric carcinoma was reported to be excellent at 465 in a phase II study However since adverse drug reactions tend to occur in patients treated with standard regimen of TS-1 drug reduction or discontinuation is often required which is one drawback of this drug On the other hand although Krestin PSK has been reported to show survival effects in postoperative immunochemotherapy against gastric carcinoma the efficacy of PSK has not been established in patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma Since the main effect of PSK was to recover physiological functions including immune function of the host it was expected that PSK would improve the compliance of TS-1 by alleviating adverse drug reactions of TS-1 therapy and the concomitant use of TS-1 with PSK would result in the improvement of treatment results Therefore we decided to conduct a randomized phase II study on patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1PSK therapy
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