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Treatment of primary g lioblastoma multiforme with c e tuximab, r adiotherapy and t emozolomide (GERT) – phase I/II trial: study protocol

Combs, Stephanie E. ; Heeger, Steffen ; Haselmann, Renate ; Edler, Lutz ; Debus, Jürgen ; Schulz-Ertner, Daniela

In: BMC Cancer, 6 (2006), Nr. 133. pp. 1-9. ISSN 1471-2407

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Download (553kB) | Lizenz: Creative Commons LizenzvertragTreatment of primary g lioblastoma multiforme with c e tuximab, r adiotherapy and t emozolomide (GERT) – phase I/II trial: study protocol by Combs, Stephanie E. ; Heeger, Steffen ; Haselmann, Renate ; Edler, Lutz ; Debus, Jürgen ; Schulz-Ertner, Daniela underlies the terms of Creative Commons Attribution 3.0 Germany

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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.

Item 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
Subjects: 610 Medical sciences Medicine
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