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Radiation Oncology
Published in: Radiation Oncology 1/2013

Open Access 01-12-2013 | Study protocol

Whole brain helical Tomotherapy with integrated boost for brain metastases in patients with malignant melanoma–a randomized trial

Authors: Henrik Hauswald, Gregor Habl, David Krug, Denise Kehle, Stephanie E Combs, Justo Lorenzo Bermejo, Jürgen Debus, Florian Sterzing

Published in: Radiation Oncology | Issue 1/2013

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Abstract

Background

Patients with malignant melanoma may develop brain metastases during the course of the disease, requiring radiotherapeutic treatment. In patients with 1–3 brain metastases, radiosurgery has been established as a treatment option besides surgery. For patients with 4 or more brain metastases, whole brain radiotherapy is considered the standard treatment. In certain patients with brain metastases, radiation treatment using whole brain helical Tomotherapy with integrated boost and hippocampal-sparing may improve prognosis of these patients.

Methods/Design

The present prospective, randomized two-armed trial aims to exploratory investigate the treatment response to conventional whole brain radiotherapy applying 30 Gy in 10 fractions versus whole brain helical Tomotherapy applying 30 Gy in 10 fractions with an integrated boost of 50 Gy to the brain metastases as well as hippocampal-sparing in patients with brain metastases from malignant melanoma. The main inclusion criteria include magnetic resonance imaging confirmed brain metastases from a histopathologically confirmed malignant melanoma in patients with a minimum age of 18 years. The main exclusion criteria include a previous radiotherapy of the brain and not having recovered from acute high-grade toxicities of prior therapies. The primary endpoint is treatment-related toxicity. Secondary endpoints include imaging response, local and loco-regional progression-free survival, overall survival and quality of life.

Trial registration

http://​www.​drks.​de Trial ID: DRKS00005127
Appendix
Available only for authorised users
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Metadata
Title
Whole brain helical Tomotherapy with integrated boost for brain metastases in patients with malignant melanoma–a randomized trial
Authors
Henrik Hauswald
Gregor Habl
David Krug
Denise Kehle
Stephanie E Combs
Justo Lorenzo Bermejo
Jürgen Debus
Florian Sterzing
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Radiation Oncology / Issue 1/2013
Electronic ISSN: 1748-717X
DOI
https://doi.org/10.1186/1748-717X-8-234

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