Abstract
BackgroundAtypical 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/DesignA 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.DiscussionROAM/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 registrationISRCTN71502099 on 19 May 2014.
Highlights
Atypical meningiomas are an intermediate grade brain tumour with a recurrence rate of 39–58 %
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
Meningiomas arise from the linings of the brain, account for 25 to 33 % of adult primary brain tumours and have a peak incidence at age 40 to 60 years [1]
Summary
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. Meningiomas arise from the linings of the brain, account for 25 to 33 % of adult primary brain tumours and have a peak incidence at age 40 to 60 years [1]. Atypical (grade II) meningioma (approximately 7 %) 3. The annual UK incidence of atypical meningioma is estimated at 0.2 to 0.5/100,000 per year and approximately 150 undergo surgical resection each year. The primary treatment for symptomatic or enlarging atypical meningioma is surgical excision, and the completeness of the resection is an important prognostic factor [5]. Simpson defined the extent of resection into five categories [5]: Simpson 1: complete tumour removal, including dural attachment and any abnormal bone
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