Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
11/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

1999 article in http://www.ncbi.nlm.nih.gov/pubmed/10549493

Publication citations

  1. 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.

Additional files

Editorial Notes