Radiation versus observation following surgical resection of atypical meningioma
| ISRCTN | ISRCTN71502099 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71502099 |
| Secondary identifying numbers | HTA 12/173/14 |
- Submission date
- 19/05/2014
- Registration date
- 19/05/2014
- Last edited
- 26/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Contact information
Scientific
The Walton Centre NHS Foundation Trust
University of Liverpool
Lower Lane
Liverpool
L9 7LJ
United Kingdom
 ORCID ID |
0000-0003-4587-2139 |
|---|
Public
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
| Phone | +44 (0)151 794 9766 |
|---|---|
| roam@liverpool.ac.uk |
Study information
| Study design | Two-arm multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial (the ROAM trial) |
| Study 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(s) | NRES Committee North East - Newcastle & North Tyneside 2, 12/02/2015, ref: 15/NE/0013 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/09/2014 |
| Overall study end date | 31/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 190 |
| Total final enrolment | 157 |
| 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 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 | 26/05/2021 |
Locations
Countries of recruitment
- Australia
- Austria
- Belgium
- England
- France
- Germany
- Ireland
- Italy
- New Zealand
- Northern Ireland
- Scotland
- Spain
- Switzerland
- United Kingdom
- Wales
Study participating centres
L9 7LJ
United Kingdom
RM7 0AG
United Kingdom
5000
Belgium
NG5 1PB
United Kingdom
CB2 0QQ
United Kingdom
OX3 7LE
United Kingdom
M6 8HD
United Kingdom
1000
Belgium
NW1 2BU
United Kingdom
EH4 2XU
United Kingdom
BS2 8ED
United Kingdom
2650
Belgium
1090
Austria
W6 8RF
United Kingdom
-
Belgium
Tremona Road
Southampton
SO16 6YD
United Kingdom
Brixton
London
SE5 9RS
United Kingdom
-
Spain
Crownhill
Plymouth
PL6 8DH
United Kingdom
-
Spain
-
Australia
-
Spain
-
Australia
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
-
France
-
Switzerland
Glossop Rd
Sheffield
S10 2JF
United Kingdom
-
France
Glasgow
G12 0XH
United Kingdom
-
Switzerland
-
Australia
-
Ireland
-
Australia
-
France
-
New Zealand
-
New Zealand
-
Italy
Germany
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Lisburn Road
Belfast
BT9 7AB
United Kingdom
-
Switzerland
-
Australia
-
Australia
-
Australia
-
Belgium
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
-
Belgium
Parc
Nantgarw
Cardiff
CF15 7QZ
United Kingdom
-
Australia
-
Switzerland
-
Italy
-
Spain
-
Australia
-
Australia
-
Germany
-
Spain
London
SW3 6JJ
United Kingdom
-
Austria
Sponsor information
Hospital/treatment centre
Lower Lane
Fazakerley
Liverpool
L9 7LJ
England
United Kingdom
| Website | https://www.thewaltoncentre.nhs.uk |
|---|---|
"ROR" |
https://ror.org/05cvxat96 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/11/2015 | Yes | No | |
| Other publications | qualiatative analysis | 01/04/2020 | 12/02/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
26/07/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2020 to 26/05/2021.
2. The overall trial end date was changed from 30/09/2025 to 31/03/2026.
3. The intention to publish date was changed from 31/03/2026 to 30/09/2026.
4. Total final enrolment added.
5. Contact details updated.
6. IPD sharing statement added.
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.
