Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479752
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2007-05-25
Brief Title:
Safety and Efficacy of Folfox4 Weekly Cetuximab vs Folfox 4Biweekly Cetuximab by Metastatic Colorectal Cancer
Sponsor:
Central European Cooperative Oncology Group
Organization:
Central European Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX4 Weekly Cetuximab Versus FOLFOX4 Biweekly Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-02
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:
CORE 2
Brief Summary:
To assess the efficacy of FOLFOX4 in combination with cetuximab weekly and FOLFOX4 in combination with cetuximab biweekly
Detailed Description:
This multicenter randomized phase II study will enroll approximately 150 patients with metastatic Colorectal Cancer Patients are randomized in Arm AFOLFOX4 in combination with weekly Cetuximab or Arm B FOLFOX4 in combination with biweekly Cetuximab Both efficacy and safety data will be collected The investigator will assess response to treatment every 8 weeks based on the imaging
Following permanent treatment cessation patients will be followed-up for survival
Following permanent treatment cessation patients will be followed-up for survival
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