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

1

Target patients

190

Open sites

24

Target Sites

62

Collaborators

eortc img
NIHR Logo
University of Liverpool Logo
The Clinical Trials Research Center

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.

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 (Appendix 1)
  • 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.

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

Recruiting Centres

In UK:

Sites Open

  • The Walton Centre opened to recruit on 28/04/2016
  • Queen's Hospital (Romford) opened to recruit on 26/10/2016
  • Nottingham University Hospitals NHS Foundation Trust opened to recruit on 01/12/2016
  • Cambridge University Hospitals NHS Foundation Trust opened to recruit on 08/12/2016
  • Oxford University Hospitals NHS Foundation Trust opened to recruit on 09/01/2017
  • Salford Royal NHS Foundation Trust opened to recruit on 31/01/17
  • University College London NHS Foundation Trust opened to recruit on 21/02/17
  • Western General Hospital, NHS Lothian opened to recruit on 08/03/17
  • University Hospitals Bristol NHS Foundation Trust to recruit on 08/03/17
  • Imperial College Healthcare NHS Trust opened to recruit on 28/04/17
  • University Hospital Southampton NHS Foundation Trust opened to recruit on 01/06/17
  • King’s College Hospital NHS Foundation Trust opened to recruit on 30/08/17
  • Plymouth Hospitals NHS Trust opened to recruit on 27/09/17

We need you to:

  • Provide signed & dated (within 2 years) CVs/GCP certificates for key members of your site team who will be involved with ROAM
  • Book in your site training visit
  • Complete your RTTQA cases prior to your training visit
  • Begin screening eligible patients at your site

In Europe:

Sites Open

  • CHU UCL Namur - Site Sainte-Elisabeth (Belgium) opened to recruitment on 15/11/2016
  • Instit Jules-Bordet (Belgium) opened to recruitment on 09/02/2017
  • Universitair Ziekenhuis Antwerpen (Belgium) opened to recruitment on 18/04/17
  • Medical University Vienna - General Hospital AKH (Austria) opened to recruitment on 26/04/17
  • Onze Lieve Vrouw Ziekenhuis (Belgium) opened to recruitment on 05/05/17
  • Complejo Hospitalario de Navarra (Spain) opened to recruitment on 07/09/17
  • Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Spain) opened to recruitment on 16/10/17
  • Institut Catala d'Oncologia - ICO Girona - Hospital Doctor Josep Trueta (Spain) opened to recruitment on 16/11/17

EORTC will be opening further sites in Austria, Belgium, France, Germany, Switzerland, The Netherlands, Italy and Spain!

In Australia:

Sites Open

  • Royal Brisbane and Women’s Hospital opened to recruitment on 03/11/17
  • Liverpool Hospital opened to recruitment on 11/12/17

Trans Tasman Radiation Oncology Group (TROG)

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:

Telephone


0151 794 9766

Address

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