Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209651
Status:
UNKNOWN
Last Update Posted:
2007-11-01
First Post:
2005-09-13
Brief Title:
Phase II Study of Oral S-1 Plus Irinotecan IRIS in Patients With Advanced Colorectal Cancer
Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Organization:
Hokkaido Gastrointestinal Cancer Study Group
Study Overview
Official Title:
Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer Hokkaido Gastrointestinal Cancer Study Group HGCSG0302
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 II study of this combination in patients with inoperable or with postoperative colorectal cancer
Detailed Description:
A multicenter Open-label single-arm phase II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan plus S-1 The usefulness of this regimens as 1st line therapy for colorectal 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRIS | None | None | None |