Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sarah Jefferies
ORCID ID
Contact details
Addenbrooke's NHS Trust Oncology Centre
Box 193
Hills Road
Cambridge
CB2 0QQ
United Kingdom
-
sarah.jefferies@addenbrookes.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00626730
Protocol/serial number
5662; EORTC protocol 22042-26042
Study information
Scientific title
Adjuvant postoperative high-dose radiotherapy for atypical and malignant meningioma: a phase-II and observation study
Acronym
Study hypothesis
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
South East Research Ethics Committee, 05/09/2008, ref: 08/H1102/43
Study design
Multicentre non-randomised interventional phase II treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
22/11/2008
Overall trial end date
28/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned sample size: 77
Participant 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
Recruitment start date
22/11/2008
Recruitment end date
28/02/2011
Locations
Countries of recruitment
Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Trial participating centre
Addenbrooke's NHS Trust Oncology Centre
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Sponsor details
Avenue E. Mounier 83
Bte 11
Brussels
B-1200
Belgium
+32 2 774 16 11
nadege.gosselin@eortc.be
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
European Organisation for Research and Treatment of Cancer
Alternative name(s)
EORTC
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Belgium
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list