|
ISRCTN
|
ISRCTN46552426
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Medical Research Council Trial of Immediate versus Deferred Treatment for Intracerebral Brain Tumours Presenting With Epilepsy
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
BR08
|
|
Study hypothesis
|
Not provided at time of registration.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration.
|
|
Study design
|
Randomised controlled trial.
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Brain and Nervous System
|
|
Participants - inclusion criteria
|
1. Patients with a clinically definite history of epilepsy who have Computed Tomography (CT) and/or Magnetic Resonance (MR) imaging supporting a probable diagnosis of intracerebral tumour
2. Clinical picture, CT or MR imaging is unequivocal and allows exclusion of cerebral abscess or extra-axial tumour (meningioma)
3. No other medical condition likely to effect the feasibility of follow-up
4. No previous neurosurgery, radiotherapy or chemotherapy
5. No other previous or concurrent malignant disease, except non melanomatous carcinoma of the skin
6. Age >16
|
|
Participants - exclusion criteria
|
Not provided at time of registration.
|
|
Anticipated start date
|
01/12/1988
|
|
Anticipated end date
|
10/12/1993
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration.
|
|
Interventions
|
1. Group A: Immediate treatment with clinicians choice of one or more of surgery, radiotherapy or chemotherapy, plus best medical treatment
2. Group B: Deferred treatment, with best medical treatment only until intervention becomes clinically necessary
|
|
Primary outcome measure(s)
|
Not provided at time of registration.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration.
|
|
Sources of funding
|
Medical Research Council (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 207 670 4723
|
|
Fax
|
+44 (0) 207 670 4818
|
|
Email
|
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
19/08/2002
|
|
Last edited
|
24/11/2010
|
|
Date ISRCTN assigned
|
19/08/2002
|
