A randomised phase III trial of focal fractionated conformal stereotactic boost following conventional radiotherapy of high grade gliomas

ISRCTN	ISRCTN37123666
DOI	https://doi.org/10.1186/ISRCTN37123666
ClinicalTrials.gov number	NCT00003916
Secondary identifying numbers	E164/8 (BR10)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Miss Sally Stenning
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email	ss@ctu.mrc.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised phase III trial of focal fractionated conformal stereotactic boost following conventional radiotherapy of high grade gliomas
Study objectives	To determine the effect of a stereotactic boost of radiotherapy on the survival time of patients with high-grade gliomas.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Survival and quality of life.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/1999
Completion date	07/12/2001

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Not Specified
Target number of participants	605
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/1999
Date of final enrolment	07/12/2001

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	article	01/04/1999		Yes	No
Results article	results	01/08/2008		Yes	No

20/09/2017: Publication reference added.