Bulbeck, H

Farrell, M

Gamble, C

Haylock, BJ

Hughes, D

Javadpour, M

Jenkinson, MD

Preusser, M

Weber, D

Young, B

University of Liverpool Repository

The ROAM / EORTC 1308 trial: Radiation versus observation following surgical resection of atypical meningioma – study updateMichael D. Jenkinson1,7*Mohsen Javadpour4Brian J. Haylock10Bridget Young8Helen Bulbeck9,11Michael Farrell5Matthias Preusser12Dyfrig Hughes14Carrol Gamble9Damien C. Weber151Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool L9 7LJ, UK. 2Neuropsychology, The Walton Centre NHS Foundation Trust, Liverpool L9 7LJ, UK. 3Neuroradiology, The Walton Centre NHS Foundation Trust, Liverpool L9 7LJ, UK. 4Department of Neurosurgery, Beaumont Hospital, Dublin 9, Ireland. 5Neuropathology, Beaumont Hospital, Dublin 9, Ireland. 6Neuroradiology, Beaumont Hospital, Dublin 9, Ireland. 7Institute of Translational Medicine, University of Liverpool, Liverpool L69 7BE, UK. 8Institute of Psychology Health and Society, University of Liverpool, Liverpool L69 7BE, UK. 9Clinical Trials Research Centre, University of Liverpool, Liverpool L69 7BE, UK. 10Department of Clinical Oncology, Clatterbridge Cancer Centre, Wirral CH63 4JY, UK. 11brainstrust, Isle of Wight PO31 7QG, UK. 12Department of Medicine, Comprehensive Cancer Center Vienna, CNS Unit, Medical University of Vienna, A-1090 Vienna, Austria. 13Department of Paediatric Neurosurgery, Alder Hey Children’s Hospital, Liverpool L12 2AP, UK. 14Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor LL57 1UT, UK. 15Centre for Proton Therapy, Paul Scherrer Institute, Villigen, Switzerland.Introduction: Atypical meningioma are very rare tumours with a recurrence rate of 30-58% at 5-years. A systematic literature review reported that the role of early adjuvant radiotherapy has not been defined and there have been no randomised controlled trials (RCT).  As part of a collaboration between NIHR and EORTC we have establised an international multi-centre RCT to determine whether early radiotherapy reduces tumour recurrence compared to observation following gross total resection of atypical meningiomaMaterials and Methods: A total of 190 patients with newly-diagnosed atypical meningioma who have undergone a Simpson I-III resection will be randomised 1:1 between early radiotherapy (60Gy in 30 fractions) & observation.  Using an estimate of 40% recurrence for the control group and 20% for the radiotherapy group then a 0.05 level two-sided log-rank test for equality of survival curves with 80% power would require 86 patients in each arm (total number of events required = 46). The primary outcome measure is time to MRI evidence of tumour recurrence (progression free survival (PFS)).  Secondary outcome measures including assessing the toxicity of radiotherapy, the quality of life, neurocognitive function, time to second line treatment, time to death (overall survival) and incremental cost per quality-adjusted life year (QALY).  Tumour tissue and serum will be collected for translational research.  Qualitative researchers will interview patients and clinicians to identify reasons for recruitment difficulties and inform recruitment strategies.Results: The trial opened in April 2016 and is planned to open in 49 sites across the UK, Europe and Australia.  4 centres are open and 2 patients have been randomised within the main trial.  4 patients have participated in the qualitative interviews.  Updated recruitment figures will be presented.Conclusions: ROAM / 1308 will provide class I evidence of the role of early adjuvant radiotherapy in the managment of atypical meningioma.  A unique bank of tissue and blood samples will be available for future translational research.Grants: Funded by the NIHR HTA programme (12/173/14).

THE ROAM / EORTC 1308 TRIAL: RADIATION VERSUS OBSERVATION FOLLOWING SURGICAL RESECTION OF ATYPICAL MENINGIOMA - STUDY UPDATE

THE ROAM / EORTC 1308 TRIAL: RADIATION VERSUS OBSERVATION FOLLOWING SURGICAL RESECTION OF ATYPICAL MENINGIOMA - STUDY UPDATE

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