Adjuvant postoperative high-dose radiotherapy for atypical and malignant meningioma
ISRCTN | ISRCTN57947111 |
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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
Contact information
Dr Sarah Jefferies
Scientific
Scientific
Addenbrooke's NHS Trust Oncology Centre
Box 193, Hills Road
Cambridge
CB2 0QQ
United Kingdom
sarah.jefferies@addenbrookes.nhs.uk |
Study information
Study design | Multicentre non-randomised interventional phase II treatment trial |
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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 |
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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
CB2 0QQ
United Kingdom
Sponsor information
European Organisation for Research and Treatment of Cancer (EORTC)
Research organisation
Research organisation
Avenue E. Mounier 83
Bte 11
Brussels
B-1200
Belgium
Phone | +32 2 774 16 11 |
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nadege.gosselin@eortc.be | |
Website | http://www.eortc.be |
https://ror.org/034wxcc35 |
Funders
Funder type
Research organisation
European Organisation for Research and Treatment of Cancer
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- EORTC
- Location
- Belgium
Results and Publications
Intention to publish date | |
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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.