Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209638
Status:
COMPLETED
Last Update Posted:
2006-04-21
First Post:
2005-09-13
Brief Title:
Phase III Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer
Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Organization:
Hokkaido Gastrointestinal Cancer Study Group
Study Overview
Official Title:
Phase III Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer Hokkaido Gastrointestinal Cancer Study Group HGCSG0101
Status:
COMPLETED
Status Verified Date:
2006-04
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:
To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period by performing a phase III study of this combination in patients with inoperable or with postoperative gastric cancer
Detailed Description:
A multicenter Open-label single-arm phase III clinical trial is conducted on patients with histological stage IV gastric cancer given irinotecan plus S-1 The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate DFR overall survival rate OS incidence and severity of adverse event
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