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 Charles (2015). The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial. Trials, 16(519), p. 519. BioMed Central 10.1186/s13063-015-1040-3

[img]
Preview
Text
art%3A10.1186%2Fs13063-015-1040-3.pdf - Published Version
Available under License Creative Commons: Attribution (CC-BY).

Download (1MB) | Preview

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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Radiation Oncology

UniBE Contributor:

Weber, Damien Charles

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1745-6215

Publisher:

BioMed Central

Language:

English

Submitter:

Beatrice Scheidegger

Date Deposited:

11 Apr 2016 08:37

Last Modified:

26 Jun 2016 02:14

Publisher DOI:

10.1186/s13063-015-1040-3

PubMed ID:

26576533

BORIS DOI:

10.7892/boris.79405

URI:

https://boris.unibe.ch/id/eprint/79405

Actions (login required)

Edit item Edit item
Provide Feedback