Condition category
Cancer
Date applied
19/05/2014
Date assigned
19/05/2014
Last edited
05/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Contact information

Type

Scientific

Primary contact

Mr Michael Jenkinson

ORCID ID

http://orcid.org/0000-0003-4587-2139

Contact details

The Walton Centre NHS Foundation Trust
University of Liverpool
Lower Lane
Liverpool
L9 7LJ
United Kingdom

Type

Public

Additional contact

Ms Priya Francis

ORCID ID

http://orcid.org/0000-0001-9748-335X

Contact details

Liverpool Clinical Trials Centre
University of Liverpool
2nd Floor Institute in the Park
Alder Hey Children’s NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 794 9766
roam@liverpool.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 12/173/14

Study information

Scientific title

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

Acronym

ROAM

Study hypothesis

Current hypothesis as of 03/05/2017:
To determine whether early adjuvant fractionated radiotherapy reduces the risk of tumour recurrence or death due to any cause compared to active monitoring in newly diagnosed atypical meningioma.

Previous hypothesis:
To determine whether early adjuvant fractionated external beam radiotherapy reduces the risk of tumour recurrence compared to active monitoring in newly diagnosed atypical meningioma.

Ethics approval

NRES Committee North East - Newcastle & North Tyneside 2, 12/02/2015, ref: 15/NE/0013

Study design

Two-arm multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Atypical meningioma

Intervention

The trial will randomise patients who have undergone gross total surgical resection of atypical (grade II) meningioma in a 1:1 ratio to either early radiotherapy (intervention) or active monitoring (comparator). Web-based randomisation will be used in this trial. Patients will be followed up for 60 months post randomisation by collecting information on signs/symptoms of tumour recurrence, 6 monthly MRI, recording of adverse events, quality of life questionnaires and cognitive function tests.

Intervention type

Device

Phase

Phase III

Drug names

Primary outcome measure

Current primary outcome measure as of 05/04/2019:
Time to MRI evidence of tumour recurrence or death due to any cause (disease free survival [DFS]). (DFS will be counted from the date of surgery until the date of MRI evidence of tumour recurrence or death due to any cause. Only clear dural thickening as identified by the investigator is to be considered tumour.)

Previous primary outcome measure:
Time to MRI evidence of tumour recurrence [disease free survival (DFS)] is assessed at baseline, 6 and 12 months following surgery and annually thereafter for a minimum of 5 years post-surgery.

Secondary outcome measures

Current secondary outcome measures as of 05/04/2019:
1. Toxicity of radiotherapy assessed by CTCAE (Common Terminology Criteria for Adverse Events)
2. Quality of life
3. Neurocognitive function (UK sites only)
4. Time to second line (salvage) treatment (surgery, radiotherapy, radiosurgery)
5. Time to death (overall survival [OS])
6. Health economic analysis (incremental cost per QALY gained) (UK sites only)

Previous secondary outcome measures:
1. Time to second line (salvage) treatment (surgery, radiotherapy, radiosurgery)
2. Time to death [overall survival (OS)]
3. Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE)
4. Quality of life is measured using the EORTC C30 and BN20 questionnaires
5. Neurocognitive function is measured using patient testing at baseline and 24 months
6. Health economic analysis (incremental cost per QALY gained) (UK sites only)

Patients will be assessed at baseline, 6 and 12 months following surgery and annually thereafter for a minimum of 5 years post-surgery unless otherwise stated.

Overall trial start date

01/09/2014

Overall trial end date

30/09/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 03/05/2017:
1. Histologically confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2016 WHO criteria
2. Age >/= 16 years
3. All anatomical locations allowed except optic nerve sheath tumour
4. Complete resection (Simpson 1, 2 or 3) as assessed by the surgeon
5. Able to commence radiotherapy between within 12 weeks of surgery (ideally 8-12 weeks)
6. WHO performance status 0, 1 or 2
7. Women of reproductive potential must use effective contraception for the whole duration of the treatment
8. 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

Previous inclusion criteria:
1. Histologically confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2007 WHO criteria
2. Age 16 years or over
3. All anatomical locations allowed except optic nerve sheath tumour
4. Complete resection (Simpson grade I, II or III) as assessed by the surgeon
5. Able to commence radiotherapy between 8 and 12 weeks after surgery
6. WHO performance status 0-2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

190

Participant exclusion criteria

Current exclusion criteria as of 05/04/2019:
1. Neurofibromatosis type II (NF-2)
2. Optic nerve sheath tumours
3. Multiple meningiomas
4. Radiation-induced meningioma
5. 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
6. Previous intracranial tumour in the last 10 years treated with radiotherapy or chemotherapy
7. Pregnant or lactating women.


Previous exclusion criteria as of 03/05/2017:
1. Neurofibromatosis type II (NF-2)
2. Optic nerve sheath tumours
3. Multiple meningiomas
4. Radiation-induced meningioma
5. 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 not been disease free for the last five years
6. Previous intracranial tumour
7. Pregnant or lactating women

Previous exclusion criteria:
1. Neurofibromatosis type II (NF-2)
2. Multiple meningiomas
3. Previous radiotherapy to the brain or meninges interfering with the protocol treatment plan
4. Clinical evidence of second malignancies, except a history of cervix carcinoma in situ and/or basal cell carcinoma
5. Pregnant or lactating women

Recruitment start date

28/04/2016

Recruitment end date

30/09/2020

Locations

Countries of recruitment

Australia, Austria, Belgium, France, Germany, Ireland, Italy, New Zealand, Spain, Switzerland, United Kingdom

Trial participating centre

The Walton Centre
Liverpool
L9 7LJ
United Kingdom

Trial participating centre

Queen’s Hospital
Romford
RM7 0AG
United Kingdom

Trial participating centre

CHU UCL Namur – Site Sainte-Elisabeth
Namur
5000
Belgium

Trial participating centre

Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Addenbrooke’s Hospital
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Churchill Hospital
Oxford
OX3 7LE
United Kingdom

Trial participating centre

Salford Royal Hospital
Manchester
M6 8HD
United Kingdom

Trial participating centre

Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
Brussels
1000
Belgium

Trial participating centre

University College London Hospital
London
NW1 2BU
United Kingdom

Trial participating centre

Western General Hospital
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

Bristol Haematology and Oncology Centre
Bristol
BS2 8ED
United Kingdom

Trial participating centre

Universitaur Ziekenhuis Antwerpen
Antwerp
2650
Belgium

Trial participating centre

Medical University Vienna - General Hospital AKH
Vienna
1090
Austria

Trial participating centre

Charing Cross Hospital (Imperial College)
London
W6 8RF
United Kingdom

Trial participating centre

Onze Lieve Vrouw Ziekenhuis
Aalst
-
Belgium

Trial participating centre

University Hospital Southampton NHS Foundation Trust
Southampton General Hospital Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

King’s College Hospital NHS Foundation Trust
Denmark Hill Brixton
London
SE5 9RS
United Kingdom

Trial participating centre

Complejo Hospitalario de Navarra
Pamplona
-
Spain

Trial participating centre

Plymouth Hospitals NHS Trust
Derriford Road Crownhill
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Barcelona
-
Spain

Trial participating centre

Royal Brisbane and Women’s Hospital
Brisbane
-
Australia

Trial participating centre

Institut Catala d'Oncologia - ICO Girona - Hospital Doctor Josep Trueta
Girona
-
Spain

Trial participating centre

Liverpool Hospital
Sydney
-
Australia

Trial participating centre

Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
Paris
-
France

Trial participating centre

UniversitaetsSpital Zurich
Zurich
-
Switzerland

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Royal Hallamshire Hospital Glossop Rd
Sheffield
S10 2JF
United Kingdom

Trial participating centre

CHRU Lille
Lille
-
France

Trial participating centre

NHS Greater Glasgow & Clyde
1055 Great Western Rd
Glasgow
G12 0XH
United Kingdom

Trial participating centre

Universitaetsspital Basel
Basel
-
Switzerland

Trial participating centre

Royal North Shore Hospital
Sydney
-
Australia

Trial participating centre

SLRON Beaumont
Dublin
-
Ireland

Trial participating centre

Peter MacCallum Cancer Centre
Melbourne
-
Australia

Trial participating centre

CHU Lyon - Hopital neurologique Pierre Wertheimer
Lyon
-
France

Trial participating centre

Waikato Hospital
Hamilton
-
New Zealand

Trial participating centre

Christchurch Hospital
Christchurch
-
New Zealand

Trial participating centre

Ospedale Bellaria
Bologna
-
Italy

Trial participating centre

Paracelsus Kliniken
-
Germany

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital Birmingham Mindelsohn Way Edgbaston
Birmingham
B15 2GW
United Kingdom

Trial participating centre

Belfast Health and Social Care Trust
Belfast City Hospital Lisburn Road
Belfast
BT9 7AB
United Kingdom

Trial participating centre

Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie
Geneva
-
Switzerland

Trial participating centre

Calvary Mater Newcastle
Newcastle
-
Australia

Trial participating centre

Princess Alexandra Hospital
Sydney
-
Australia

Trial participating centre

ROPART (Radiation Oncology Princess Alexandra Hospital Raymond Terrace)
Brisbane
-
Australia

Trial participating centre

GasthuisZusters Antwerpen - Sint-Augustinus
Antwerp
-
Belgium

Trial participating centre

University Hospitals of North Midlands NHS Trust
Royal Stoke University Hospital Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Trial participating centre

Cliniques Universitaires Saint-Luc
Brussels
-
Belgium

Trial participating centre

Velindre NHS Trust
Unit 2 Charnwood Court Heol Billingsley Parc Nantgarw
Cardiff
CF15 7QZ
United Kingdom

Trial participating centre

Westmead Hospital
Sydney
-
Australia

Trial participating centre

Centre Hospitalier Universitaire Vaudois - Lausanne
Lausanne
-
Switzerland

Trial participating centre

Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
-
Italy

Trial participating centre

Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona
-
Spain

Trial participating centre

Chris O'Brien Lifehouse
Sydney
-
Australia

Trial participating centre

Sir Charles Gairdner Hospital
Nedlands
-
Australia

Trial participating centre

Universitaetsklinikum Bonn
Bonn
-
Germany

Trial participating centre

Hospital Universitario 12 De Octubre
Madrid
-
Spain

Trial participating centre

Royal Marsden NHS Foundation Trust
Fulham Road
London
SW3 6JJ
United Kingdom

Trial participating centre

Innsbruck Universitaetsklinik
Innsbruck
-
Austria

Sponsor information

Organisation

The Walton Centre NHS Foundation Trust (UK)

Sponsor details

Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

https://www.thewaltoncentre.nhs.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The communication and dissemination strategy will actively involve participating centres, their staff, service users and the professional bodies involved (Society of British Neurological Surgeons, British Neuro-Oncology Society) and relevant charitable organisations (brainstrust, The Brain Tumour Charity, MeningiomaUK), in discussing the proposed trial prior to its implementation and reviewing trial progress and results. Communication and dissemination of results, including findings from the embedded qualitative study relevant to clinical trial methodology, will be assisted by members of the study team, several of whom have leading roles in research and quality of practice activities across the NHS. Findings of the trial will be presented at National and International meetings of relevant professional bodies and research groups. The results of the trial will be published in peer-reviewed journals. Publication is anticipated in 2024/2025. Updates on trial progress will be presented at conferences throughout the recruitment period.

Intention to publish date

31/03/2026

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26576533
2020 qualiatative analysis in https://www.ncbi.nlm.nih.gov/pubmed/32045067 (added 12/02/2020)

Publication citations

Additional files

Editorial Notes

05/05/2020: The following changes have been made: 1. The public contact's ORCID has been added and her address updated. 2. Chris O'Brien Lifehouse, Sir Charles Gairdner Hospital, Universitaetsklinikum Bonn, Hospital Universitario 12 De Octubre, Royal Marsden NHS Foundation Trust and Innsbruck Universitaetsklinik have been added to the trial participating centres. 3. Austria, France and Germany were added to the countries of recruitment. 04/05/2020: Due to current public health guidance, recruitment for this study has been paused. 12/02/2020: Publication reference added. 05/04/2019: The following changes were made to the trial record: 1. The recruitment end date was changed from 31/03/2019 to 30/09/2020 2. The overall end date was changed from 31/07/2024 to 30/09/2025 3. The intention to publish date was changed from 31/12/2024 to 31/03/2026 4. The trial website was changed from http://roam-trial.org.uk/new/index_new.html to http://www.roam-trial.org.uk/ 5. The address for the public contact was changed from 'The Walton Centre NHS Foundation Trust University of Liverpool, Lower Lane, Liverpool, L9 7LJ' to 'Clinical Trials Research Centre, 2nd Floor – Institute in the Park, Alder Hey Children’s NHS Foundation Trust, Eaton Road, Liverpool, L12 2AP' 6. The intervention type was changed from other to device, and the phase was added (phase III) 7. The primary outcome measure was changed 8. The secondary outcome measures were changed 9. The exclusion criteria were changed 10. The countries of recruitment were changed from 'Austria, Belgium, UK' to 'UK, Ireland, Belgium, Spain, Australia, France, Switzerland, New Zealand, Italy' 11. The following trial participating centres were added: Onze Lieve Vrouw Ziekenhuis (Belgium); University Hospital Southampton NHS Foundation Trust; King’s College Hospital NHS Foundation Trust; Complejo Hospitalario de Navarra (Spain); Plymouth Hospitals NHS Trust; Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Spain); Royal Brisbane and Women’s Hospital (Brisbane, Australia); Institut Catala d'Oncologia - ICO Girona - Hospital Doctor Josep Trueta (Spain); Liverpool Hospital (Sydney, Australia); Newcastle upon Tyne Hospitals NHS Foundation Trust; Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (France); UniversitaetsSpital Zurich (Switzerland); Sheffield Teaching Hospitals NHS Foundation Trust CHRU Lille (France); NHS Greater Glasgow & Clyde; Universitaetsspital Basel (Switzerland); Royal North Shore Hospital (Sydney, Australia); SLRON Beaumont (Dublin); Peter MacCallum Cancer Centre (Melbourne, Australia); CHU Lyon - Hopital neurologique Pierre Wertheimer (France); Waikato Hospital (Hamilton, New Zealand); Christchurch Hospital (Christchurch, New Zealand); Ospedale Bellaria (Italy); Parcelsus Kliniken (Germany); University Hospitals Birmingham NHS Foundation Trust; Belfast Health and Social Care Trust; Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Switzerland); Calvary Mater Newcastle (Newcastle, Australia); Princess Alexandra Hospital (Sydney, Australia); ROPART (Radiation Oncology Princess Alexandra Hospital Raymond Terrace) (Brisbane, Australia); GasthuisZusters Antwerpen - Sint-Augustinus (Belgium); University Hospitals of North Midlands NHS Trust; Cliniques Universitaires Saint-Luc (Belgium); Velindre NHS Trust (Cardiff); Westmead Hospital (Sydney, Australia); Centre Hospitalier Universitaire Vaudois - Lausanne (Switzerland); Fondazione IRCCS Istituto Neurologico Carlo Besta (Italy); Institut Catala d'Oncologia - Hospital Duran i Reynals (Spain). 03/05/2017: The following changes were made to the trial record: 1. The recruitment end date was changed from 31/07/2024 to 31/03/2019. 2. Austria and Belgium were added to the countries of recruitment. 05/01/2017: Cancer Help UK lay summary link added to plain English summary field. 12/05/2016: Ethics approval information added. The recruitment start date has been updated from 01/09/2014 to 28/04/2016 and Ms Priya Francis has been added as a public study contact.