A study of adjuvant chemotherapy for malignant glioma
| ISRCTN | ISRCTN81218776 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81218776 |
| Protocol serial number | BR05 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 12/04/2012
- 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=101
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 whether the addition of chemotherapy to a standard radiotherapy regime influences the survival of adult patients with malignant glioma (astrocytomas grades 3 & 4) and to assess the ability of in vitro chemosensitivity testing to identify patients with a better prognosis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | 1. One group receives chemotherapy added to a standard radiotherapy regimen 2. The other group receives none |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Chemotherapy |
| Primary outcome measure(s) |
Survival time |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 69 Years |
| Sex | All |
| Target sample size at registration | 600 |
| Key inclusion criteria | 1. Age 18-69 2. No previous treatment except surgery, corticosteroids, anticonvulsants or diuretics 3. Entry within 6 weeks of surgery 4. Other malignancies 5. Fitness for treatment |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/1988 |
| 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 | 15/01/2001 | Yes | No |
