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The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial

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posted on 2022-12-01, 17:09 authored by Michael D Jenkinson, Mohsen JavadpourMohsen Javadpour, Brian J Haylock, Bridget Young, Helen Gillard, Jacqui Vinten, Helen Bulbeck, Kumar Das, Michael Farrell, S�amus LoobyS�amus Looby, Helen Hickey, Mattheus Preusser, Conor L Mallucci, Dyfrig Hughes, Carrol Gamble, Damien C Weber

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/design: 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.

Discussion: 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.

Trial registration: ISRCTN71502099 on 19 May 2014.

Funding

National Institute of Health Research Health Technology Assessment (NIHR-HTA) programme (project number 12/173/14)

Brain Tumour and Radiation Oncology groups of the EORTC

History

Comments

The original article is available at https://trialsjournal.biomedcentral.com/

Published Citation

Jenkinson MD. et al. The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial. Trials. 2015;16:519.

Publication Date

14 November 2015

PubMed ID

26576533

Department/Unit

  • Beaumont Hospital

Publisher

BioMed Central

Version

  • Published Version (Version of Record)