Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316745
Status:
SUSPENDED
Last Update Posted:
2007-11-01
First Post:
2006-04-19
Brief Title:
IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer
Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Organization:
Hokkaido Gastrointestinal Cancer Study Group
Study Overview
Official Title:
Irinotecan Combined With S-1 IRIS Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer
Status:
SUSPENDED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Because of approval of Bevacizumab it was difficult to perform clinical study in 1st line setting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase III study compares safety and efficacy of two sequence arms in advanced colorectal cancer irinotecan and S-1 IRIS followed by oxaliplatin containing regimen arm A or l-leucovorin l-LV 5-FU and oxaliplatin mFOLFOX6 followed by irinotecan containing regimen arm B
Detailed Description:
A multicenter randomized open-label controlled phase III study is conducted in patients with inoperable advanced or metastatic colorectal cancer who receive no previous chemotherapy Usefulness of IRIS and mFOLFOX6 regimens as the 1st-line therapy for colorectal cancer is evaluated in PFS MST incidence and severity of adverse events
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 |
|---|---|---|---|
| IFOX study | None | None | None |