title: The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Atypical meningiomas are an intermediate grade brain tumour with a recurrence rate of 39-58 %. It is not known whether early adjuvant radiotherapy reduces the risk of tumour recurrence and whether the potential side-effects are justified. An alternative management strategy is to perform active monitoring with magnetic resonance imaging (MRI) and to treat at recurrence. There are no randomised controlled trials comparing these two approaches.
  
  
  METHODS
  A total of 190 patients will be recruited from neurosurgical/neuro-oncology centres across the United Kingdom, Ireland and mainland Europe. Adult patients undergoing gross total resection of intracranial atypical meningioma are eligible. Patients with multiple meningioma, optic nerve sheath meningioma, previous intracranial tumour, previous cranial radiotherapy and neurofibromatosis will be excluded. Informed consent will be obtained from patients. This is a two-stage trial (both stages will run in parallel): Stage 1 (qualitative study) is designed to maximise patient and clinician acceptability, thereby optimising recruitment and retention. Patients wishing to continue will proceed to randomisation. Stage 2 (randomisation) patients will be randomised to receive either early adjuvant radiotherapy for 6 weeks (60 Gy in 30 fractions) or active monitoring. The primary outcome measure is time to MRI evidence of tumour recurrence (progression-free survival (PFS)). Secondary outcome measures include assessing the toxicity of the radiotherapy, the quality of life, neurocognitive function, time to second line treatment, time to death (overall survival (OS)) and incremental cost per quality-adjusted life year (QALY) gained.
  
  
  CONCLUSIONS
  ROAM/EORTC-1308 is the first multi-centre randomised controlled trial designed to determine whether early adjuvant radiotherapy reduces the risk of tumour recurrence following complete surgical resection of atypical meningioma. The results of this study will be used to inform current neurosurgery and neuro-oncology practice worldwide.
  
  
  BACKGROUND
  ISRCTN71502099 on 19 May 2014.
authors.affiliation: Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ, UK. michael.jenkinson@liv.ac.uk.|Institute of Translational Medicine, University of Liverpool, Liverpool, L69 7BE, UK. michael.jenkinson@liv.ac.uk.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Jenkinson
authors.affiliation: Department of Neurosurgery, Beaumont Hospital, Dublin 9, Ireland. mjavadpour@me.com.
authors.forename: Mohsen
authors.initials: M
authors.lastname: Javadpour
authors.affiliation: Department of Clinical Oncology, Clatterbridge Cancer Centre, Wirral, CH63 4JY, UK. brian.haylock@clatterbridgecc.nhs.uk.
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Haylock
authors.affiliation: Institute of Psychology Health and Society, University of Liverpool, Liverpool, L69 7BE, UK. byoung@liv.ac.uk.
authors.forename: Bridget
authors.initials: B
authors.lastname: Young
authors.affiliation: Neuropsychology, The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ, UK. hgillard@liv.ac.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Gillard
authors.affiliation: Neuropsychology, The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ, UK. jacqui.vinten@thewaltoncentre.nhs.uk.|Institute of Translational Medicine, University of Liverpool, Liverpool, L69 7BE, UK. jacqui.vinten@thewaltoncentre.nhs.uk.
authors.forename: Jacqui
authors.initials: J
authors.lastname: Vinten
authors.affiliation: Clinical Trials Research Centre, University of Liverpool, Liverpool, L69 7BE, UK. helen@brainstrust.org.uk.|brainstrust, Isle of Wight, PO31 7QG, UK. helen@brainstrust.org.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Bulbeck
authors.affiliation: Neuroradiology, The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ, UK. kumar.das@thewaltoncentre.nhs.uk.
authors.forename: Kumar
authors.initials: K
authors.lastname: Das
authors.affiliation: Neuropathology, Beaumont Hospital, Dublin 9, Ireland. michaelfarrell@baeumont.ie.
authors.forename: Michael
authors.initials: M
authors.lastname: Farrell
authors.affiliation: Neuroradiology, Beaumont Hospital, Dublin 9, Ireland. seamuslooby@beaumont.ie.
authors.forename: Seamus
authors.initials: S
authors.lastname: Looby
authors.affiliation: Clinical Trials Research Centre, University of Liverpool, Liverpool, L69 7BE, UK. h.hickey@liv.ac.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Hickey
authors.affiliation: Department of Medicine, Comprehensive Cancer Center Vienna, CNS Unit, Medical University of Vienna, A-1090, Vienna, Austria. matthias.preusser@meduniwien.ac.at.
authors.forename: Mattheus
authors.initials: M
authors.lastname: Preusser
authors.affiliation: Institute of Translational Medicine, University of Liverpool, Liverpool, L69 7BE, UK. cmallucci@me.com.|Department of Paediatric Neurosurgery, Alder Hey Children's Hospital, Liverpool, L12 2AP, UK. cmallucci@me.com.
authors.forename: Conor L
authors.initials: CL
authors.lastname: Mallucci
authors.affiliation: Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, LL57 1UT, UK. d.a.hughes@bangor.ac.uk.
authors.forename: Dyfrig
authors.initials: D
authors.lastname: Hughes
authors.affiliation: Clinical Trials Research Centre, University of Liverpool, Liverpool, L69 7BE, UK. c.gamble@liv.ac.uk.
authors.forename: Carrol
authors.initials: C
authors.lastname: Gamble
authors.affiliation: Centre for Proton Therapy, Paul Scherrer Institute, Villigen, Switzerland. damien.weber@psi.ch.
authors.forename: Damien C
authors.initials: DC
authors.lastname: Weber
mesh_terms: D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D016371:Cranial Irradiation / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D018450:Disease Progression; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005060:Europe; D017048:Health Care Costs; D006801:Humans; D008279:Magnetic Resonance Imaging; D008577:Meningeal Neoplasms / Q000175:diagnosis / Q000191:economics / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery*; D008579:Meningioma / Q000175:diagnosis / Q000191:economics / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery*; D009364:Neoplasm Recurrence, Local / Q000191:economics / Q000517:prevention & control*; D019635:Neurosurgical Procedures / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D011237:Predictive Value of Tests; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D018714:Radiotherapy, Adjuvant; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome