A joint MRC/European Organisation for Research and Treatment of Cancer (EORTC) study of radiotherapy for low grade astrocytomas and oligodendrogliomas
| ISRCTN | ISRCTN17931175 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17931175 |
| Protocol serial number | BR04 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 14/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=100
Contact information
Dr Hannah Brooks
Scientific
Scientific
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 | |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | Two groups - post-operative radiotherapy and no post-operative radiotherapy. |
| Intervention type | Other |
| Primary outcome measure(s) |
Survival time, Morbidity, Time to progression |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 250 |
| Key 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 |
| Key exclusion criteria | History of cardiac disease |
| Date of first enrolment | 01/08/1986 |
| Date of final enrolment | 30/06/1996 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2005 | Yes | No |
