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INTRAGO: intraoperative radiotherapy in glioblastoma multiforme – a Phase I/II dose escalation study

Giordano, Frank Anton ; Brehmer, Stefanie ; Abo-Madyan, Yasser ; Welzel, Grit ; Sperk, Elena ; Keller, Anke ; Schneider, Frank ; Clausen, Sven ; Herskind, Carsten ; Schmiedek, Peter ; Wenz, Frederik

In: BMC Cancer, 15 (2014), Nr. 992. pp. 1-9. ISSN 1471-2407

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Download (386kB) | Lizenz: Creative Commons LizenzvertragINTRAGO: intraoperative radiotherapy in glioblastoma multiforme – a Phase I/II dose escalation study by Giordano, Frank Anton ; Brehmer, Stefanie ; Abo-Madyan, Yasser ; Welzel, Grit ; Sperk, Elena ; Keller, Anke ; Schneider, Frank ; Clausen, Sven ; Herskind, Carsten ; Schmiedek, Peter ; Wenz, Frederik underlies the terms of Creative Commons Attribution 3.0 Germany

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Abstract

Background: Glioblastoma multiforme (GBM) is the most frequent primary malignant brain tumor in adults. Despite multimodal therapies, almost all GBM recur within a narrow margin around the initial resected lesion. Thus, novel therapeutic intensification strategies must target both, the population of dispersed tumor cells around the cavity and the postoperative microenvironment. Intraoperative radiotherapy (IORT) is a pragmatic and effective approach to sterilize the margins from persistent tumor cells, abrogate post-injury proliferative stimuli and to bridge the therapeutic gap between surgery and radiochemotherapy. Therefore, we have set up INTRAGO, a phase I/II dose-escalation study to evaluate the safety and tolerability of IORT added to standard therapy in newly diagnosed GBM. In contrast to previous approaches, the study involves the application of isotropic low-energy (kV) x-rays delivered by spherical applicators, providing optimal irradiation properties to the resection cavity. Methods/Design: INTRAGO includes patients aged 50 years or older with a Karnofsky performance status of at least 50% and a histologically confirmed (frozen sections) supratentorial GBM. Safety and tolerability (i.e., the maximum tolerated dose, MTD) will be assessed using a classical 3 + 3 dose-escalation design. Dose-limiting toxicities (DLT) are wound healing deficits or infections requiring surgical intervention, IORT-related cerebral bleeding or ischemia, symptomatic brain necrosis requiring surgical intervention and early termination of external beam radiotherapy (before the envisaged dose of 60 Gy) due to radiotoxicity. Secondary end points are progression-free and overall survival. Trial registration: The study is registered with clinicaltrials.gov, number: NCT02104882 (Registration Date: 03/26/2014).

Item Type: Article
Journal or Publication Title: BMC Cancer
Volume: 15
Number: 992
Publisher: BioMed Central
Place of Publication: London
Date Deposited: 22 Dec 2015 09:21
Date: 2014
ISSN: 1471-2407
Page Range: pp. 1-9
Faculties / Institutes: Medizinische Fakultät Mannheim > Neurochirurgische Klinik
Medizinische Fakultät Mannheim > Klinik für Strahlentherapie und Radioonkologie
Subjects: 610 Medical sciences Medicine
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