Condition category
Cancer
Date applied
19/05/2014
Date assigned
19/05/2014
Last edited
03/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact details

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

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

31/07/2024

Reason abandoned

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 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

31/03/2019

Locations

Countries of recruitment

Austria, Belgium, 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
1000
Belgium

Trial participating centre

University College London Hospital
NW1 2BU
United Kingdom

Trial participating centre

Western General Hospital
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

Bristol Haematology and Oncology Centre
BS2 8ED
United Kingdom

Trial participating centre

Universitaur Ziekenhuis Antwerpen
2650
Belgium

Trial participating centre

Medical University Vienna - General Hospital AKH
1090
Austria

Trial participating centre

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

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

Federal/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

31/12/2024

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26576533

Publication citations

Additional files

Editorial Notes

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.