Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.