Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311857
Status:
UNKNOWN
Last Update Posted:
2006-09-08
First Post:
2006-04-05
Brief Title:
Safety Study of Cetuximab Radiotherapy and Temozolomide in Primary Glioblastoma MultiformeGERT
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Treatment of Primary Glioblastoma Multiforme With Cetuximab Radiotherapy and Temozolomide GERT - Phase III Trial
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
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:
GERT is a one-armed single-center phase III trial In a first step dose-escalation of TMZ from 50 mgm2 to 75mgm2 together with radiotherapy and cetuximab will be performed Should safety be proven the phase II trial will be initiated with the standard dose of 75mgm2 of TMZ Cetuximab will be applied in the standard application dose of 400mgm2 in week 1 thereafter at a dose of 250mgm2 weekly A total of 46 patients will be included into this phase III trial
Primary endpoints are feasibility and toxicity secondary endpoints are overall and progression-free survival An interim analysis will be performed after inclusion of 15 patients into the main study Patients enrolment will be performed over a period of 2 years The observation time will end 2 years after inclusion of the last patient
Primary endpoints are feasibility and toxicity secondary endpoints are overall and progression-free survival An interim analysis will be performed after inclusion of 15 patients into the main study Patients enrolment will be performed over a period of 2 years The observation time will end 2 years after inclusion of the last patient
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PEI 11901 | None | None | None |