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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

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...

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Autores principales: Jenkinson, Michael D., Javadpour, Mohsen, Haylock, Brian J., Young, Bridget, Gillard, Helen, Vinten, Jacqui, Bulbeck, Helen, Das, Kumar, Farrell, Michael, Looby, Seamus, Hickey, Helen, Preusser, Mattheus, Mallucci, Conor L., Hughes, Dyfrig, Gamble, Carrol, Weber, Damien C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4650615/
https://www.ncbi.nlm.nih.gov/pubmed/26576533
http://dx.doi.org/10.1186/s13063-015-1040-3
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author Jenkinson, Michael D.
Javadpour, Mohsen
Haylock, Brian J.
Young, Bridget
Gillard, Helen
Vinten, Jacqui
Bulbeck, Helen
Das, Kumar
Farrell, Michael
Looby, Seamus
Hickey, Helen
Preusser, Mattheus
Mallucci, Conor L.
Hughes, Dyfrig
Gamble, Carrol
Weber, Damien C.
author_facet Jenkinson, Michael D.
Javadpour, Mohsen
Haylock, Brian J.
Young, Bridget
Gillard, Helen
Vinten, Jacqui
Bulbeck, Helen
Das, Kumar
Farrell, Michael
Looby, Seamus
Hickey, Helen
Preusser, Mattheus
Mallucci, Conor L.
Hughes, Dyfrig
Gamble, Carrol
Weber, Damien C.
author_sort Jenkinson, Michael D.
collection PubMed
description 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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spelling pubmed-46506152015-11-19 The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial Jenkinson, Michael D. Javadpour, Mohsen Haylock, Brian J. Young, Bridget Gillard, Helen Vinten, Jacqui Bulbeck, Helen Das, Kumar Farrell, Michael Looby, Seamus Hickey, Helen Preusser, Mattheus Mallucci, Conor L. Hughes, Dyfrig Gamble, Carrol Weber, Damien C. Trials Study Protocol 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. BioMed Central 2015-11-14 /pmc/articles/PMC4650615/ /pubmed/26576533 http://dx.doi.org/10.1186/s13063-015-1040-3 Text en © Jenkinson et al. 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Jenkinson, Michael D.
Javadpour, Mohsen
Haylock, Brian J.
Young, Bridget
Gillard, Helen
Vinten, Jacqui
Bulbeck, Helen
Das, Kumar
Farrell, Michael
Looby, Seamus
Hickey, Helen
Preusser, Mattheus
Mallucci, Conor L.
Hughes, Dyfrig
Gamble, Carrol
Weber, Damien C.
The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial
title The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial
title_full The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial
title_fullStr The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial
title_full_unstemmed The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial
title_short The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial
title_sort roam/eortc-1308 trial: radiation versus observation following surgical resection of atypical meningioma: study protocol for a randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4650615/
https://www.ncbi.nlm.nih.gov/pubmed/26576533
http://dx.doi.org/10.1186/s13063-015-1040-3
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