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Open Access 01-12-2018 | Study protocol

Whole brain radiation therapy alone versus radiosurgery for patients with 1–10 brain metastases from small cell lung cancer (ENCEPHALON Trial): study protocol for a randomized controlled trial

Authors: Denise Bernhardt, Adriane Hommertgen, Daniela Schmitt, Rami El Shafie, Angela Paul, Laila König, Johanna Mair-Walther, Johannes Krisam, Christina Klose, Thomas Welzel, Juliane Hörner-Rieber, Jutta Kappes, Michael Thomas, Claus Peter Heußel, Martin Steins, Meinhard Kieser, Jürgen Debus, Stefan Rieken

Published in: Trials | Issue 1/2018

Abstract

Background

Conventional whole brain radiotherapy (WBRT) has been established as the treatment standard in patients with cerebral metastases from small-cell lung cancer (SCLC), however, it has only modest efficacy and limited prospective data is available for WBRT as well as local treatments such as stereotactic radiosurgery (SRS).

Methods/design

The present single-center prospective randomized study, conducted at Heidelberg University Hospital, compares neurocognitive function, as objectively measured by significant deterioration in Hopkins Verbal Learning Test – Revised total recall at 3 months. Fifty-six patients will be randomized to receive either SRS of all brain metastases (up to ten lesions) or WBRT. Secondary endpoints include intracranial progression (local tumor progression and number of new cerebral metastases), extracranial progression, overall survival, death due to brain metastases, local (neurological) progression-free survival, progression-free survival, changes in other cognitive performance measures, quality of life and toxicity.

Discussion

Recent evidence suggests that SRS might be a promising treatment option for SCLC patients with brain metastases. The present trial is the first to prospectively investigate the treatment response, toxicity and neurocognition of WBRT and SRS in SCLC patients.

Trial registration

Clinicaltrials.gov NCT03297788. Registered September 29, 2017.

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Title: Whole brain radiation therapy alone versus radiosurgery for patients with 1–10 brain metastases from small cell lung cancer (ENCEPHALON Trial): study protocol for a randomized controlled trial
Authors: Denise Bernhardt
Adriane Hommertgen
Daniela Schmitt
Rami El Shafie
Angela Paul
Laila König
Johanna Mair-Walther
Johannes Krisam
Christina Klose
Thomas Welzel
Juliane Hörner-Rieber
Jutta Kappes
Michael Thomas
Claus Peter Heußel
Martin Steins
Meinhard Kieser
Jürgen Debus
Stefan Rieken
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-018-2745-x

ACC 2024 Congress

Springer Medicine

Whole brain radiation therapy alone versus radiosurgery for patients with 1–10 brain metastases from small cell lung cancer (ENCEPHALON Trial): study protocol for a randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

ACC 2024 Congress

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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