Contact information
Type
Scientific
Primary contact
Miss Sally Stenning
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
-
ss@ctu.mrc.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003916
Protocol/serial number
E164/8 (BR10)
Study information
Scientific title
A randomised phase III trial of focal fractionated conformal stereotactic boost following conventional radiotherapy of high grade gliomas
Acronym
Study hypothesis
To determine the effect of a stereotactic boost of radiotherapy on the survival time of patients with high-grade gliomas.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cancer
Intervention
The trial is designed to randomise patients between two treatment arms:
1. Conventional radiotherapy
2. Conventional radiotherapy plus a stereotactic boost
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Survival and quality of life.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1999
Overall trial end date
07/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically confirmed gliomas World Health Organisation (WHO) III/IV, no previous histology of low grade tumours WHO I/II
2. Tumour volumes less than 4.0 cm
3. No tumours in brain stem or infratentorial location, no multifocal gliomas
4. Ability to treat tumour safely by stereotactic radiotherapy
5. Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0-2
6. Patient able to tolerate full course of conventional radiotherapy
7. Prior neurosurgery within 6 weeks of randomisation
8. Aged greater than 18 and less than 65 years
9. Informed consent
10. No prior chemo- or radiotherapy
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
605
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/1999
Recruitment end date
07/12/2001
Locations
Countries of recruitment
Australia, France, Germany, Netherlands, Spain, Switzerland, United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
1999 article in https://www.ncbi.nlm.nih.gov/pubmed/10549493
2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18455252
Publication citations
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Article
Brada M, Baumert B, Focal fractionated conformal stereotactic boost following conventional radiotherapy of high-grade gliomas: a randomized phase III study. A joint study of the EORTC (22972) and the MRC (BR10)., Front Radiat Ther Oncol, 1999, 33, 241-243.