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 designMulticentre non-randomised interventional phase II treatment trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleAdjuvant postoperative high-dose radiotherapy for atypical and malignant meningioma: a phase II and observation study
Study objectivesThis 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) studiedTopic: National Cancer Research Network; Subtopic: Brain Tumour; Disease: Brain and Nervous System
InterventionSimpson 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 typeProcedure/Surgery
Primary outcome measure1. 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 measuresOverall 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 date22/11/2008
Completion date28/02/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsPlanned sample size: 77
Total final enrolment78
Key inclusion criteria1. 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 criteria1. 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 enrolment22/11/2008
Date of final enrolment28/02/2011

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.