Adjuvant postoperative high-dose radiotherapy for atypical and malignant meningioma

ISRCTN	ISRCTN57947111
DOI	https://doi.org/10.1186/ISRCTN57947111
ClinicalTrials.gov number	NCT00626730
Secondary identifying numbers	5662; EORTC protocol 22042-26042

Submission date: 21/10/2010
Registration date: 21/10/2010
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-radiotherapy-after-surgery-treat-type-brain-tumour-meningioma

Contact information

Dr Sarah Jefferies
Scientific

Addenbrooke's NHS Trust Oncology Centre
Box 193, Hills Road
Cambridge
CB2 0QQ
United Kingdom

Email	sarah.jefferies@addenbrookes.nhs.uk

Study information

Study design	Multicentre non-randomised interventional phase II treatment trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Adjuvant postoperative high-dose radiotherapy for atypical and malignant meningioma: a phase II and observation study
Study objectives	This study is looking at how effective radiotherapy after surgery can be at preventing the reoccurance of meningioma, a type of brain tumour. The aims of this study are to see: 1. How long high dose radiotherapy stops the meningioma coming back for 2. How well people cope with the treatment 3. How well people having the treatment can carry out simple instructions and tasks afterwards
Ethics approval(s)	South East Research Ethics Committee, 05/09/2008, ref: 08/H1102/43
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Brain Tumour; Disease: Brain and Nervous System
Intervention	Simpson grade 1 - 3: 60 Gy to the CTV1, treatment duration 6 weeks Simpson grade 4 - 5: 60 Gy to the CTV1 and then 10Gy boost to CTV2, treatment duration 7 weeks Follow up on both arms: 1st follow up 6 weeks post last irradiation, 2nd follow up will be 6 months after trial entry, 3rd follow up at 12 months and yearly thereafter.
Intervention type	Procedure/Surgery
Primary outcome measure	1. Three year progression free survival (PFS) 2. Acute and long term toxicity Measured at baseline, during treatment, 6 weeks after end of radiotherapy (RT), 6 months after trial entry, 12 months after trial entry and then yearly. For both endpoints, the patients not having experienced the event(s) of interest are censored at the date of most recent follow-up.
Secondary outcome measures	Overall survival (OS), measured from date of entry to date of death, irrespective of the cause. For both endpoints, the patients not having experienced the event(s) of interest are censored at the date of most recent follow-up.
Overall study start date	22/11/2008
Completion date	28/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned sample size: 77
Total final enrolment	78
Key inclusion criteria	1. Histologically confirmed newly diagnosed meningioma, including the following subtypes (atypical World Health Organisation [WHO] grade II meningioma greater than or equal to 4 mitosis per high-power field [HPF] or the presence of at least 3 of the following variables): 1.1. Cellularity 1.2. Architectural sheeting (i.e., patternless pattern) 1.3. Macronuclei cell formation 1.4. Small cell formation 1.5. Malignant WHO grade III meningioma 2. All locations allowed except for optic nerve sheets tumours 3. Complete or subtotal resection as assessed by the surgeon after verification with a post-operative magnetic resonance imaging (MRI) and according to Simpson guidelines 4. No neurofibromatosis type 2 (NF-2) 5. Female, aged 53 - 67 years
Key exclusion criteria	1. No optic nerve sheet tumours nor neurofibromatosis type II 2. No previous radiation therapy to the meninges or brain 3. No second malignancies 4. 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
Date of first enrolment	22/11/2008
Date of final enrolment	28/02/2011

Locations

Countries of recruitment

Belgium
England
France
Germany
Italy
Netherlands
Spain
Switzerland
United Kingdom

Study participating centre

Addenbrooke's NHS Trust Oncology Centre

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

European Organisation for Research and Treatment of Cancer (EORTC)
Research organisation

Avenue E. Mounier 83
Bte 11
Brussels
B-1200
Belgium

Phone	+32 2 774 16 11
Email	nadege.gosselin@eortc.be
Website	http://www.eortc.be
"ROR"	https://ror.org/034wxcc35

Funders

Funder type

Research organisation

European Organisation for Research and Treatment of Cancer
Private sector organisation / Other non-profit organizations

Alternative name(s): EORTC
Location: Belgium

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	quality assurance results	30/01/2013	07/03/2019	Yes	No
Results article	results	01/08/2018	07/03/2019	Yes	No
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
07/03/2019: Publication reference added.
29/03/2018: No publications found, verifying study status with principal investigator.
11/02/2016: No publications found, verifying study status with principal investigator.