Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial (The ROAM trial)

ROAM is a multi-centre, randomised controlled trial to compare radiotherapy versus active monitoring in patients who have undergone gross total surgical resection (Simpson 1-3) of atypical (grade II) meningioma.

The primary objective of the ROAM trial is to determine whether early adjuvant fractionated external beam radiotherapy reduces the risk of tumour recurrence compared to active monitoring in newly diagnosed atypical meningioma.

Meningiomas comprise 25-33% of adult primary brain tumours. The annual UK incidence of atypical meningioma is 0.2-0.5 / 100,000 / year and ~150 undergo surgical resection each year. Since the publication of the 2000 WHO classification, the reported incidence of atypical meningioma has risen to 20-35%, nevertheless they remain very rare.

Benign (grade I) meningioma have a low risk of recurrence (~10% at 5 years) following surgical resection and are managed by active monitoring with MRI scans. Adjuvant radiotherapy is indicated for anaplastic (grade III) meningioma to prolong time to recurrence however 5-year progression free survival is only ~10%.

The role of radiotherapy in atypical (grade II) meningioma after gross total resection has not been defined and there is no agreement on the current standard of care for patients with atypical meningioma.

Patients with the following characteristics will be eligible for inclusion in the trial:

• Histologically confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2016 WHO criteria
• Age >/= 16 years
• All anatomical locations allowed except optic nerve sheath tumour
• Complete resection (Simpson 1, 2 or 3) as assessed by the surgeon
• Able to commence radiotherapy between within 12 weeks of surgery (ideally 8-12 weeks)
• WHO performance status 0, 1 or 2 (Appendix 1)
• Women of reproductive potential must use effective contraception for the whole duration of the treatment
• h) 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 in the trial.

Patients with the following characteristics will be excluded from the trial:

• Neurofibromatosis type II (NF-2)
• 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
• Pregnant or lactating women

Participants will be randomised via the EORTC Online Randomised Trials Access (ORTA) system. ORTA runs in a standard web browser, requires Java to be installed on the PC being used and can be accessed here. The log in details to be used are the same as those assigned for the EORTC database.

The ORTA system will show the following screen:

• The 'Institution number' can be found on the top of your screening log
• The 'Protocol' number will always be 1308 for the ROAM trial
• The 'Step' will always be 1 - New Patient for the ROAM trial
• Select the PI name from the list given
• The 'Patient code' will be the screening code assigned to the participant on the screening log
• The 'Patient birth date' will be entered and you will then click 'Start'

ORTA will go through the inclusion/ exclusion criteria, one by one. Once a participant is randomised, a message will appear detailing the allocated arm; this information will also be emailed to the PI/ROAM team. Approximately 1 hour after randomisation, the participant's CRFs will be visible on the EORTC database.

In case of problems randomising online, randomisation can be carried out via the EORTC call centre: (+32) 2774 1600. The call centre is available 09:00 - 17:00 (Belgian local time) from Monday to Friday. Randomisation via the call centre is not available on Belgian holidays - a list of these holidays is available on the EORTC website and is updated annually.