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
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
Affiliations
Denise Bernhardt
Department of Radiation Oncology, University Hospital Heidelberg
Adriane Hommertgen
Department of Radiation Oncology, University Hospital Heidelberg
Daniela Schmitt
Department of Radiation Oncology, University Hospital Heidelberg
Rami El Shafie
Department of Radiation Oncology, University Hospital Heidelberg
Angela Paul
Department of Radiation Oncology, University Hospital Heidelberg
Laila König
Department of Radiation Oncology, University Hospital Heidelberg
Johanna Mair-Walther
Department of Neurooncology, University Hospital of Heidelberg
Johannes Krisam
Institute of Medical Biometry and Informatics, University of Heidelberg
Christina Klose
Institute of Medical Biometry and Informatics, University of Heidelberg
Thomas Welzel
Department of Radiation Oncology, University Hospital Heidelberg
Juliane Hörner-Rieber
Department of Radiation Oncology, University Hospital Heidelberg
Jutta Kappes
Department of Pneumology, Thoraxklinik, Heidelberg University
Michael Thomas
Department of Thoracic Oncology. Translational Lung Research Centre Heidelberg (TLRC-H), Thoraxklinik, Heidelberg University
Claus Peter Heußel
Translational Lung Research Centre Heidelberg (TLRC-H), German Centre for Lung Research (DZL)
Martin Steins
Department of Thoracic Oncology. Translational Lung Research Centre Heidelberg (TLRC-H), Thoraxklinik, Heidelberg University
Meinhard Kieser
Institute of Medical Biometry and Informatics, University of Heidelberg
Jürgen Debus
Department of Radiation Oncology, University Hospital Heidelberg
Stefan Rieken
Department of Radiation Oncology, University Hospital Heidelberg
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.
