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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Michael D. Jenkinson, Mohsen Javadpour, Brian J. Haylock, Bridget Young, Helen Gillard, Jacqui Vinten, Helen Bulbeck, Kumar Das, Michael Farrell, Seamus Looby, Helen Hickey, Mattheus Preusser, Conor L. Mallucci, Dyfrig Hughes, Carrol Gamble, Damien C. Weber

Published in: Trials | Issue 1/2015

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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/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.
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Metadata
Title
The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial
Authors
Michael D. Jenkinson
Mohsen Javadpour
Brian J. Haylock
Bridget Young
Helen Gillard
Jacqui Vinten
Helen Bulbeck
Kumar Das
Michael Farrell
Seamus Looby
Helen Hickey
Mattheus Preusser
Conor L. Mallucci
Dyfrig Hughes
Carrol Gamble
Damien C. Weber
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-1040-3

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