Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01044225
Status:
TERMINATED
Last Update Posted:
2012-03-22
First Post:
2010-01-06
Brief Title:
Effect of Radiation Therapy Plus Temozolomide Combined With Cilengitide or Cetuximab on the 1-year Overall Survival of Patients With Newly Diagnosed MGMT-promoter Unmethylated Glioblastoma
Sponsor:
Bart Neyns
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
CeCil A Randomized Non-comparative Clinical Trial of the Effect of Radiation Therapy Plus Temozolomide Combined With Cilengitide or Cetuximab on the 1-year Overall Survival of Patients With Newly Diagnosed MGMT-promoter Unmethylated Glioblastoma
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Results of the phase III RTOG0525 trial made the manufacturer of cilengitide decide to end their support to the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators propose to conduct a multicenter open-label randomized phase II study in patients with newly diagnosed glioblastoma CeCil Patients should meet all eligibility criteria for the CENTRIC phase III trial at the exception that no MGMT-promoter methylation could be demonstrated The treatment backbone in both study arms will consist of postoperative radiation therapy with concomitant daily temozolomide followed by 6 cycles of temozolomide according to a 21 out of 28 days regimen as in the experimental arm of the RTOG 0525 EORTC 26052-22053 phase III study In study arm A Cilengitide at a dose of 2000 mg by iv administration 2xweek will be added to this backbone while in the second study arm B Cetuximab will be added at an initial dose of 400 mgm² administered by intravenous infusion over 2 hours and followed by a weekly dose of 250 mgm² iv over 1 hours In both study arms treatment will be administered for 52 consecutive treatment weeks The 1-year overall survival 1y-OS following randomization will serve as the primary endpoint in both study arms
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