In: BMC Cancer, 6 (2006), Nr. 133. pp. 1-9. ISSN 1471-2407
Preview |
PDF, English
Download (553kB) | Lizenz: Creative Commons Attribution 3.0 Germany |
Abstract
Background: The implementation of combined radiochemotherapy (RCHT) with temozolomide (TMZ) has lead to a significant increase in overall survival times in patients with Glioblastoma multiforme (GBM), however, outcome still remains unsatisfactory. The majority of GBMs show an overexpression and/or amplification of the epidermal growth factor receptor (EGFR). Therefore, addition of EGFR-inhibition with cetuximab to the current standard treatment approach with radiotherapy and TMZ seems promising. Methods/design: GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ from 50 mg/m2 to 75 mg/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 75 mg/m2 of TMZ. Cetuximab will be applied in the standard application dose of 400 mg/m2 in week 1, thereafter at a dose of 250 mg/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. Discussion: The goal of this study is to evaluate the safety and efficacy of combined RCHT-immunotherapy with TMZ and cetuximab as first-line treatment for patients with primary GBM.
Document type: | Article |
---|---|
Journal or Publication Title: | BMC Cancer |
Volume: | 6 |
Number: | 133 |
Publisher: | BioMed Central; Springer |
Place of Publication: | London; Berlin; Heidelberg |
Date Deposited: | 02 Mar 2016 07:39 |
Date: | 2006 |
ISSN: | 1471-2407 |
Page Range: | pp. 1-9 |
Faculties / Institutes: | Service facilities > German Cancer Research Center (DKFZ) Medizinische Fakultät Heidelberg > Radiologische Universitätsklinik |
DDC-classification: | 610 Medical sciences Medicine |