Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
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|ClinicalTrials.gov Identifier: NCT00311857|
Recruitment Status : Unknown
Verified September 2006 by Heidelberg University.
Recruitment status was: Recruiting
First Posted : April 6, 2006
Last Update Posted : September 8, 2006
GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. Should safety be proven, the phase II trial will be initiated with the standard dose of 75mg/m2 of TMZ. Cetuximab will be applied in the standard application dose of 400mg/m2 in week 1, thereafter at a dose of 250mg/m2 weekly. A total of 46 patients will be included into this phase I/II 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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: Cetuximab Drug: Temozolomide Procedure: Radiation therapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) – Phase I/II Trial|
|Study Start Date :||February 2006|
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311857
|Contact: Daniela Schulz-Ertner, MD||+49-6221-56 ext 8201||Daniela.Ertner@med.uni-heidelberg.de|
|Contact: Stephanie E Combs, MD||+49-6221-56 ext 8201||Stephanie.Combs@med.uni-heidelberg.de|
|University of Heidelberg||Recruiting|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Contact: Daniela Schulz-Ertner, MD +49-6221-56 ext 8201 Daniela.Ertner@med.uni-heidelberg.de|
|Contact: Stephanie E Combs, MD +49-6221-56 ext 8201 Stephanie.Combs@med.uni-heidelberg.de|
|Principal Investigator: Daniela Schulz-Ertner, MD|
|Sub-Investigator: Stephanie E Combs, MD|
|Principal Investigator:||Daniela Schulz-Ertner, MD||Heidelberg University|