title: Treatment of primary g lioblastoma multiforme with c e tuximab, r adiotherapy and t emozolomide (GERT) – phase I/II trial: study protocol
creator: Combs, Stephanie E.
creator: Heeger, Steffen
creator: Haselmann, Renate
creator: Edler, Lutz
creator: Debus, Jürgen
creator: Schulz-Ertner, Daniela
subject: ddc-610
subject: 610 Medical sciences Medicine
description: 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.
publisher: BioMed Central; Springer
date: 2006
type: Article
type: info:eu-repo/semantics/article
type: NonPeerReviewed
format: application/pdf
identifier: https://archiv.ub.uni-heidelberg.de/volltextserverhttps://archiv.ub.uni-heidelberg.de/volltextserver/20236/1/12885_2006_Article_485.pdf
identifier: DOI:
identifier: urn:nbn:de:bsz:16-heidok-202365
identifier:   Combs, Stephanie E. ; Heeger, Steffen ; Haselmann, Renate ; Edler, Lutz ; Debus, Jürgen ; Schulz-Ertner, Daniela  (2006) Treatment of primary g lioblastoma multiforme with c e tuximab, r adiotherapy and t emozolomide (GERT) – phase I/II trial: study protocol.  BMC Cancer, 6 (133).  pp. 1-9.  ISSN 1471-2407     
relation: https://archiv.ub.uni-heidelberg.de/volltextserver/20236/
rights: info:eu-repo/semantics/openAccess
rights: Please see front page of the work (Sorry, Dublin Core plugin does not recognise license id)
language: eng