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Open Access Highly Accessed Study protocol

Treatment of patients with atypical meningiomas Simpson grade 4 and 5 with a carbon ion boost in combination with postoperative photon radiotherapy: The MARCIE Trial

Stephanie E Combs1*, Lutz Edler2, Iris Burkholder6, Stefan Rieken1, Daniel Habermehl1, Oliver Jäkel3, Thomas Haberer3, Andreas Unterberg4, Wolfgang Wick5, Jürgen Debus1 and Renate Haselmann1

Author Affiliations

1 Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany

2 Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, 69120 Heidelberg, Germany

3 Heidelberger Ionenstrahl Therapiezentrum (HIT), Im Neuenheimer Feld 450, 69120 Heidelberg, Germany

4 Department of Neurosurgery, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany

5 Department of Neurooncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany

6 StaBiL, Statistische und Biometrische Lösungen, Pistorstr. 7, 66482 Zweibruecken, Germany

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BMC Cancer 2010, 10:615  doi:10.1186/1471-2407-10-615

Published: 9 November 2010

Abstract

Background

Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50% and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.

Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.

First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.

Methods/design

The Phase II-MARCIE-Study will evaluate a carbon ion boost applied to the macroscopic tumor in conjunction with photon radiotherapy in patients with atypical menigiomas after incomplete resection or biopsy.

Primary endpoint is progression-free survival, secondary endpoints are overall survival, safety and toxicity.

Discussion

Based on published data on the treatment of atypical meningiomas with carbon ions at GSI, the present study will evaluate this treatment concept in a larger patient population and will compare outcome to current standard photon treatment.

Trial registration

NCT01166321