Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433927
Status:
UNKNOWN
Last Update Posted:
2014-03-14
First Post:
2007-02-09
Brief Title:
5-FU Folinic Acid and Irinotecan FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment Colorectal Cancer CRC
Sponsor:
PD Dr med Volker Heinemann
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Multicenter Randomized Trial Evaluating FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment of Metastatic Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2014-03
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:
The FIRE-3 trial is a multicenter randomized phase III trial investigating 5-FU folinic acid and irinotecan FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab in first line treatment of metastatic colorectal cancer Planned accrual is 284 evaluable patients per treatment arm The primary study endpoint is objective response rate Secondary endpoints are median progression free survival median overall survival safety and secondary resection rate
Detailed Description:
None
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