Recipient organisationWalton Centre NHS Foundation TrustSource-published name: The Walton Centre NHS Foundation Trust
Funding£1.4M
PeriodNov 2014 — Sept 2026
In plain English
AI plain-English summary
After surgery to remove an atypical meningioma—a brain tumour with a high risk of regrowing—patients are being randomly assigned to either immediate radiotherapy or active monitoring with scans, to settle a long-standing clinical debate. This matters because atypical meningiomas sit in a grey zone: they are not benign enough to ignore, but not malignant enough for clear treatment guidelines. Currently, doctors lack high-quality evidence on whether early radiotherapy improves outcomes or simply exposes patients to unnecessary side effects. The ROAM trial directly addresses this gap by comparing disease-free survival between the two approaches across 21 UK and Ireland neurosurgery units, with additional sites in Europe and Australasia. If the trial shows that early radiotherapy significantly delays tumour recurrence without unacceptable toxicity, it could change standard practice overnight—sparing thousands of patients from repeat surgeries and the anxiety of waiting for regrowth. Conversely, if active monitoring proves equivalent, patients would avoid radiation’s long-term cognitive and quality-of-life costs. The embedded health economic analysis will tell the NHS whether the intervention is worth its cost, using EQ-5D-5L data and Hospital Episode Statistics to calculate cost per QALY gained.
View original technical description
Design: two-arm, multi-centre, randomised controlled trial. This will be a pragmatic trial randomising patients who have undergone gross total resection (GTR) of atypical meningioma to early radiotherapy or active monitoring Main trial: randomisation to early radiotherapy or active monitoring in a ratio of 1:1 Embedded qualitative study: will identify and implement bespoke strategies to enhance recruitment ensuring successful trial delivery After randomisation, patients in both arms will undergo a baseline MRI up to 10 weeks after surgery. Neurocognitive function (NCF) will be tested up to 12 weeks after surgery, and then 2 years after surgery. Adjuvant radiotherapy will commence 8-12 weeks after surgery. Setting: 21 neurosurgery and oncology units in UK & Ireland. 34 neurosurgery and oncology units across Europe and Australasia (not funded by NIHR). Target population: patients who have undergone gross total resection of atypical meningioma Inclusion criteria: • Histology confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2016 WHO criteria • Age >/= 16 years • All locations except optic nerve sheath • Complete (Simpson grade I-III) resection assessed by surgeon • WHO performance status 0-2 • Women of reproductive potential must use effective contraception for the whole duration of the treatment • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration to the trial Exclusion criteria: • Neurofibromatosis type II • Optic nerve sheath tumours • Multiple meningiomas • Radiation-induced meningioma • Clinical evidence of second malignancy, except for cervix carcinoma in-situ or basal cell carcinoma, and history of invasive malignancy unless treated with curative intent and the patient has been disease free for the last five years • Previous intracranial tumour in the last 10 years treated with radiotherapy or chemotherapy • Pregnant or lactating women Health technologies being assessed: a) Surgical resection + active monitoring with MRI and clinic follow-up (comparator) b) Surgical resection + early adjuvant fractionated radiotherapy (intervention) Measurement of costs and outcomes: There are no established Core Outcomes for brain tumour patients (COMET website searched). • Primary outcome: -Time to MRI evidence of tumour recurrence or death due to any cause (disease free survival) • Secondary outcomes: - Toxicity assessed by CTCAE (Common Terminology Criteria for Adverse Events) - Quality of life - Neurocognitive function (UK sites only) - Time to second line (salvage) treatment (surgery, radiotherapy, radiosurgery) - Time to death (overall survival) - Health economic analysis (incremental cost per QALY gained) (UK sites) Health economic analysis: There are no existing economic studies of treatment options in atypical meningioma and to assess the balance of the potential benefits of reduced recurrence rates against the costs, we will conduct a cost utility analysis, from the perspective of the NHS. Resource use will be based on entries made in designated sections of patients' case report forms; complemented with Hospital Episode Statistics data sourced from the NHS Digital for patients recruited in England, and data from hospital Patient Administration Systems. Unit costs will be obtained from NHS reference costs and other relevant NHS resources. The number of QALY gained will be estimated by administering the EQ-5D-5L and applying a UK tariff for generating utilities. An economic (Markov) model will be specified with appropriate health states to project lifetime costs and consequences. Costs and QALYs occurring after the first year will be discounted at 3.5% per annum. Incremental cost-effectiveness ratios will be compared with threshold values, and the joint unc
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