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The rationale and development of a CyberKnife© registry for pediatric patients with CNS lesions

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Abstract

Background

CyberKnife© Radiosurgery (CKRS) is a recognized treatment concept for CNS lesions in adults due to its high precision and efficacy beside a high patient comfort. However, scientific evidence for this treatment modality in pediatric patients is scarce. A dedicated registry was designed to document CyberKnife© procedures in children, aiming to test the hypothesis that it is safe and efficient for the treatment of CNS lesions.

Methods

The CyberKnife© registry is designed as a retrospective and prospective multicenter observational study (German Clinical Trials Register (https://www.drks.de), DRKS-ID 00016973). Patient recruitment will be ongoing throughout a 5-year period and includes collection of demographic, treatment, clinical, and imaging data. Follow-up results will be monitored for 10 years. All data will be registered in a centralized electronic database at the Charité-Universitätsmedizin. The primary endpoint is stable disease for benign and vascular lesions at 5 years of follow-up and local tumor control for malign lesions at 1- and 2-year follow-up. Secondary endpoints are radiation toxicity, side effects, and neurocognitive development.

Conclusion

The CyberKnife© registry intends to generate scientific evidence for all treatment- and outcome-related aspects in pediatric patients with treated CNS lesions. The registry may define safety and efficacy of CKRS in children and serve as a basis for future clinical trials, inter-methodological comparisons and changes of treatment algorithms.

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

APRO:

Arbeitsgemeinschaft für pädiatrische Radioonkologie (Working group for Pediatric Radiation Oncology)

CKRS:

CyberKnife radiosurgery

CNS:

Central nervous system

DGN:

Deutsche Gesellschaft für Neurologie (German Society of Neurology)

MRI:

Magnet resonance imaging

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Acknowledgments

We thank Karin Dieckmann at the Department of Radiotherapy, Medical University, Beate Timmermann at the Clinic for Particle Therapy, University Hospital Essen, Germany and Ralf-Dieter Kortmann at the Department of Radiation Therapy, University of Leipzig, Germany for conducting the external review of the study protocol during the annual meeting of the Working group for Pediatric Radiation Oncology. We thank John Adler and Michael S.B. Edwards at the Department of Neurosurgery, Stanford University School of Medicine, Stanford, California, USA for their supportive advice, encouragement and methodical review.

Pediatric CyberKnife© Registry Study Group

Berlin—A. Grün, P. Vajkoczy, LN. Lohkamp; Erfurt—S. Fichte, HU. Herold; Frankfurt am Main—R. Wolff; Göppingen—G. Becker, M. Bleif; Güstrow—S. Huttenlocher, S. Wurster; Hamburg—F. Fehlauer, T. Schneider; Heidelberg—S. Rieken, J. Debus; Köln—S. Marnitz-Schulze, MI. Ruge; München—M. Kufeld, A.Muacevic; Soest—R. Lehrke; Villingen-Schwenningen—S. Mose, G. Skazikis.

Funding

The study was not funded. The authors report no conflict of interest concerning the methods used in this study or the findings specified in this paper.

Author information

Authors and Affiliations

  1. Department of Neurosurgery with Pediatric Neurosurgery, Charité – Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany

    Laura-Nanna Lohkamp, Julius Dengler & Peter Vajkoczy

  2. Division of Neurosurgery, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G2J9, Canada

    Laura-Nanna Lohkamp

  3. Department of Radiation Oncology and Radiotherapy, Charité – Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany

    Arne Grün & Volker Budach

  4. Charité CyberKnife Center, Charité – Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany

    Arne Grün

  5. Brandenburg Medical School Theodor Fontane, Campus Bad Saarow, Bad Saarow, Germany

    Julius Dengler

  6. Department of Neurosurgery, Helios Clinic, Bad Saarow, Germany

    Julius Dengler

  7. European CyberKnife Center Munich, Max Lebsche Platz 31, 81377, Munich, Germany

    Markus Kufeld

Authors
  1. Laura-Nanna Lohkamp
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Consortia

on behalf of the Pediatric CyberKnife© Registry Study Group

Contributions

LNL developed the protocol, set up the multicenter cooperation and wrote the manuscript. AG and JD gave advice on study protocol and provided corrections for the manuscript. PV and VB supervised the study. MK was the main contributor in developing the study protocol and created the study-specific database.

Corresponding author

Correspondence to Laura-Nanna Lohkamp.

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Conflicts of interest

There are no conflicts of interest or competing interests to report by any of the authors.

Ethics approval and consent to participate

An ethics approval for this registry study was obtained by the ethics committee of the Charité –Universitätsmedizin in Berlin in January 2018 (EA2_232_17). All CyberKnife Centers in Germany gave written consent for participation in the study according to the described protocol. The study was registered at the German Clinical Trials Register (https://www.drks.de), DRKS-ID 00016973.

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All authors reviewed the final manuscript and gave consent for publication in Child’s Nervous System.

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Lohkamp, LN., Grün, A., Dengler, J. et al. The rationale and development of a CyberKnife© registry for pediatric patients with CNS lesions. Childs Nerv Syst 37, 871–878 (2021). https://doi.org/10.1007/s00381-020-04944-5

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  • DOI: https://doi.org/10.1007/s00381-020-04944-5

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