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ISRCTN
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ISRCTN37123666
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DOI
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10.1186/ISRCTN37123666
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ClinicalTrials.gov identifier
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NCT00003916
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EudraCT number
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Public title
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A randomised phase III trial of focal fractionated conformal stereotactic boost following conventional radiotherapy of high grade gliomas
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Scientific title
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Acronym
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N/A
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Serial number at source
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E164/8 (BR10)
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Study hypothesis
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To determine the effect of a stereotactic boost of radiotherapy on the survival time of patients with high-grade gliomas.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom, International
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Disease/condition/study domain
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Cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/04/1999
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Anticipated end date
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07/12/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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605
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Interventions
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The trial is designed to randomise patients between two treatment arms:
1. Conventional radiotherapy
2. Conventional radiotherapy plus a stereotactic boost
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Primary outcome measure(s)
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Survival and quality of life.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1999 article in http://www.ncbi.nlm.nih.gov/pubmed/10549493
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Contact name
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Miss
Sally
Stenning
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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ss@ctu.mrc.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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30/07/2009
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Date ISRCTN assigned
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06/04/2000
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