Medical Research Council Trial of Immediate versus Deferred Treatment for Intracerebral Brain Tumours Presenting With Epilepsy
| ISRCTN | ISRCTN46552426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46552426 |
| Protocol serial number | BR08 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 15/11/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Medical Research Council Trial of Immediate versus Deferred Treatment for Intracerebral Brain Tumours Presenting With Epilepsy |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Brain and Nervous System |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/12/1993 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/1988 |
| Date of final enrolment | 10/12/1993 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
15/11/2019: Study stopped due to poor recruitment.
21/01/2019: No publications found. All search options exhausted.