Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286130
Status:
COMPLETED
Last Update Posted:
2012-05-01
First Post:
2006-02-02
Brief Title:
Safety and Efficacy of Folfox6 Cetuximab Versus Folfiri Cetuximab in Patients With Metastatic Colorectal Cancer
Sponsor:
Central European Cooperative Oncology Group
Organization:
Central European Cooperative Oncology Group
Study Overview
Official Title:
A Randomised Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-04
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:
In Patients with metastatic colorectal cancer the following treatments first-line FolfiriCetuximab first-line Folfox6 Cetuximab will be concerning efficacy and safety
The trial compares Folfiri Cetuximab and Folfox6 Cetuximab concerning efficacy and safety as first
The trial compares Folfiri Cetuximab and Folfox6 Cetuximab concerning efficacy and safety as first
Detailed Description:
The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC
EGFR expression is not required for study entry however the EGFR status will be measured retrospectively
Patients are randomized to Arm A or Arm B Arm A FOLFOX 6 in combination with cetuximab Arm B FOLFIRI in combination with cetuximab Both efficacy and safety data will be collected The investigators will assess response to treatment at 6 weeks 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation stop of all study treatments patients will be followed-up for
EGFR expression is not required for study entry however the EGFR status will be measured retrospectively
Patients are randomized to Arm A or Arm B Arm A FOLFOX 6 in combination with cetuximab Arm B FOLFIRI in combination with cetuximab Both efficacy and safety data will be collected The investigators will assess response to treatment at 6 weeks 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation stop of all study treatments patients will be followed-up for
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 |
|---|---|---|---|
| EUDRACT number 2004-002391-42 | None | None | None |