Radiation versus Observation following surgery for Atypical Meningioma
Research type
Research Study
Full title
Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial (The ROAM trial)
IRAS ID
159719
Contact name
Michael Jenkinson
Contact email
ISRCTN Number
ISRCTN71502099
Duration of Study in the UK
9 years, 10 months, 30 days
Research summary
Atypical meningioma is an intermediate grade brain tumour that arises from the linings of the brain. These are very rare tumours and there are approximately 150 new cases per year in the UK, and tend to affect adults with a peak incidence at age 40-60 years. The 5-year tumour recurrence rates are reported as between 39 and 58%. The primary treatment for atypical meningioma is surgery and in patients with residual solid tumour, radiotherapy is administered to reduce the risk of recurrence. In patients with complete resection of the tumour, some clinicians give early radiotherapy, whilst others advise active monitoring with radiotherapy given only at recurrence. Whilst radiotherapy has been shown to be an effective adjuvant treatment in some studies but not others, there is no consensus as to which of these approaches is best. Following resection surgery for atypical meningioma, eligible patients will be randomised to receive either radiotherapy or active monitoring. Patients in both arms will typically have an early post-operative follow-up within 2 weeks of resection surgery to discuss the histopathology results and assess wounds and clinical status. Follow-up thereafter would be at 6 months, 12 months and annually until tumour recurrence or trial closure. EORTC C30 and BN20 quality of life, EQ-5D health outcome, and resource use questionnaires will be administered at each follow up visit. All participants will be followed up for a minimum of 5 years post-surgery.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0013
Date of REC Opinion
12 Feb 2015
REC opinion
Further Information Favourable Opinion