Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
Recruitment status was: Recruiting
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.
Procedure: Radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) – Phase I/II Trial|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311857
|University of Heidelberg|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Principal Investigator:||Daniela Schulz-Ertner, MD||Heidelberg University|