Condition category
Cancer
Date applied
19/05/2014
Date assigned
19/05/2014
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

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

Medicines for Children Clinical Trials Unit
Clinical Trials Research Centre (CTRC)
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

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

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1217314

Ethics approval

NRES Committee North East - Newcastely & 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 below 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

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

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

31/07/2024

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Walton Centre NHS Foundation Trust
Liverpool
L9 7LJ
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

NIHR Health Technology Assessment Programme - HTA (UK); Ref. 12/173/14

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

24/11/2016: Internal review. 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. 08/03/2016: Internal review.