Plain English Summary
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=100
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
BR04
Study information
Scientific title
Acronym
Study hypothesis
To assess the value of post-operative radiotherapy in the management of low grade (1 & 2) astrocytoma and oligodendroglioma.
Ethics approval(s)
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Cancer
Intervention
Two groups - post-operative radiotherapy and no post-operative radiotherapy.
Intervention type
Other
Primary outcome measure
Survival time, Morbidity, Time to progression
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/08/1986
Overall study end date
30/06/1996
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 16-66
2. World Health Organisation (WHO) performance status 0-2
3. Neurosurgery within past 8 weeks
4. No previous malignancy
5. No previous treatment except surgery
6. Corticosteroids, anticonvulsants or diuretics
7. No condition likely to prejudice treatment or follow up
Participant type(s)
Patient
Age group
Adult
Sex
Not Specified
Target number of participants
250
Participant exclusion criteria
History of cardiac disease
Recruitment start date
01/08/1986
Recruitment end date
30/06/1996
Locations
Countries of recruitment
England, United Kingdom
Study 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)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2005 | Yes | No |