Overview

Welcome to the ROAM Trial website

ROAM is a multi-centre, randomised controlled trial. The trial will randomise patients who have undergone gross total surgical resection of atypical (grade II) meningioma to receive either early adjuvant fractionated radiotherapy for 6 weeks (intervention) or active monitoring (comparator).

The trial is funded by the National Institute for Health Research's Health Technology Assessment Programme (NIHR HTA) and is sponsored by The Walton Centre NHS Foundation Trust. The day-to-day running of the trial, monitoring and analysis is being coordinated by a team at the Clinical Trials Research Centre (CTRC) at University of Liverpool. The data managment aspect of the trial will be managed by The European Organisation for Research and Treatment of Cancer (EORTC), Belgium.

The ROAM trial opened for recruitment on 28/04/16 at The Walton Centre. For a current list of open sites, please see 'Recruiting Centres.'

Randomised patients

39

Target patients

190

Open sites

46

Target Sites

63

Information for Patients

Want more information about the ROAM trial? Watch the video below:

Information for Sites and Clinicians

ROAM Webinar to Help Optimise Recruitment 26/04/18

Patient Inclusion Criteria

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
  • 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 in the trial.

Patient Exclusion Criteria

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 in the last 10 years treated with radiotherapy or chemotherapy
  • Pregnant or lactating women

Collaborators

NIHR Logo
The Walton Centre NHS
University of Liverpool Logo
The Clinical Trials Research Center
eortc img
TROG
CTI

Study funder

National Institute for Health Research's Health Technology Assessment Programme (NIHR HTA) (Project 12/173/14)

Study organiser

Clinical Trials Research Centre (CTRC), University of Liverpool

Study review and approval

The study has been reviewed by a research ethics committee (North East – Newcastle & North Tyneside 2), who have agreed the study is being conducted in a correct and appropriate manner.

Trial Summary

Overview

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.

Why are we doing this research study?

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.

Recruiting Centres

In the UK and Ireland:

Sites Open to Recruitment

  • The Walton Centre (Liverpool) opened 28/04/16
  • Queen's Hospital (Romford) opened 26/10/16
  • Nottingham City Hospital opened 01/12/16
  • Addenbrooke's Hospital (Cambridge) opened 08/12/16
  • Churchill Hospital (Oxford) opened 09/01/17
  • Salford Royal Hospital (Manchester) opened 31/01/17
  • University College London Hospital opened 21/02/17
  • Western General Hospital (Edinburgh) opened 08/03/17
  • Bristol Haematology and Oncology Centre opened 27/03/17
  • Charing Cross Hospital (London) opened 28/04/17
  • Southampton General Hospital opened 01/06/17
  • King's College Hospital (London) opened 30/08/17
  • Derriford Hospital (Plymouth) opened 27/09/17
  • Northern Centre for Cancer Care (Freeman Hospital, Newcastle) opened 20/12/17
  • Weston Park Hospital (Sheffield) opened 30/01/18
  • Beatson West of Scotland Cancer Centre (Glasgow) opened 22/02/18
  • SLRON Beaumont (Dublin) opened 12/03/18
  • Queen Elizabeth Hospital (Birmingham) opened 20/04/18
  • Royal Victoria Hospital (Belfast) opened 04/05/18
  • Royal Stoke University Hospital opened 12/07/18

In Europe:

Sites Open to Recruitment

  • CHU UCL Namur - Site Sainte-Elisabeth (Belgium) opened 15/11/16
  • Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (Belgium) opened 09/02/17
  • Universitair Ziekenhuis Antwerpen (Belgium) opened 18/04/17
  • Medical University Vienna - General Hospital AKH (Austria) opened 26/04/17
  • Onze Lieve Vrouw Ziekenhuis (Belgium) opened 05/05/17
  • Complejo Hospitalario de Navarra (Spain) opened 07/09/17
  • Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Spain) opened 16/10/17
  • Institut Catala d'Oncologia - ICO Girona - Hospital Doctor Josep Trueta (Spain) opened 16/11/17
  • Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (France) opened 02/01/18
  • UniversitaetsSpital Zurich (Switzerland) opened 23/01/18
  • CHRU Lille (France) opened 06/02/18
  • Universitaetsspital Basel (Switzerland) opened 06/03/18
  • CHU Lyon - Hopital neurologique Pierre Wertheimer (France) opened 27/03/18
  • Ospedale Bellaria (Italy) opened 09/04/18
  • Parcelsus Kliniken (Germany) opened 16/04/18
  • Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Switzerland) opened 14/05/18
  • GasthuisZusters Antwerpen - Sint-Augustinus (Belgium) opened 11/07/18

In Australia and New Zealand:

Sites Open to Recruitment

  • Royal Brisbane and Women's Hospital (Brisbane, AUS) opened 03/11/17
  • Liverpool Hospital (Sydney, AUS) opened 11/12/17
  • Royal North Shore Hospital (Sydney, AUS) opened 08/03/18
  • Peter MacCallum Cancer Centre (Melbourne, AUS) opened 15/03/18
  • Waikato Hospital (Hamilton, NZ) opened 03/04/18
  • Christchurch Hospital (Christchurch, NZ) opened 05/04/18
  • Calvary Mater Newcastle (Newcastle, AUS) opened 29/05/18
  • Princess Alexandra Hospital (Sydney, AUS) opened 05/06/18
  • ROPART (Radiation Oncology Princess Alexandra Hospital Raymond Terrace) (Brisbane, AUS) opened 05/06/18

Randomisation

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:

ORTA Screenshot

  • 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.

Contacts

Please feel free to contact the ROAM study team by any of the means below:

UK and Ireland
(Clinical Trials Research Centre, CTRC)

roam@liverpool.ac.uk

ROAM Trial
Clinical Trials Research Centre
University of Liverpool
Institute of Child Health
Alder Hey Children's NHS Foundation Trust
Liverpool
L12 2AP

Europe (European Organisation for Research and Treatment of Cancer, EORTC)

1308@eortc.org

ROAM/1308 Trial
EORTC Headquarters
Av. E. Mounierlaan 83/11
1200 Brussels
Belgium

Australia & New Zealand
(Trans Tasman Radiation Oncology Group, TROG)

ROAM@trog.com.au

ROAM/15.02 Trial
TROG Central Operations Office
PO Box 88
Waratah
NSW
2298

Data Protection Queries

DPO@thewaltoncentre.nhs.uk

Carol Johnson
Head of Data Protection/Data Protection Officer at The Walton Centre NHS Foundation Trust
Tel: 0151 556 3036