A study of radiotherapy with or without chemotherapy in primary central nervous system (CNS) lymphoma
| ISRCTN | ISRCTN77275134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77275134 |
| Protocol serial number | BR06 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 29/07/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
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
Miss Sally Stenning
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| ss@ctu.mrc.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To evaluate the effect of CHOP chemotherapy on event-free and overall survival. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | Group 1: radiotherapy alone (54 Gy total dose in 27 fractions) Group 2: radiotherapy as above, followed after 4 weeks by six cycles of CHOP chemotherapy given at 3-week intervals (cyclophosphamide 750 mg/m^2 iv, adriamycin 50 mg/m^2 iv, vincristine 1.4 mg/m^2 iv (max 2 mg) and prednisolone (20 mg po tds for 5 days) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | CHOP chemotherapy |
| Primary outcome measure(s) |
Survival. |
| Key secondary outcome measure(s) |
Event-free survival. |
| Completion date | 01/10/1995 |
| Reason abandoned (if study stopped) | Slow accrual |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Not Specified |
| Target sample size at registration | 90 |
| Key inclusion criteria | 1. Pathologically proven primary cerebral lymphoma 2. Aged 18-75 3. No previous radiotherapy or chemotherapy 4. Adequate neurological, physical and mental function |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/1988 |
| Date of final enrolment | 01/10/1995 |
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 in: GM Mead, NM Bleehen, A Gregor, J Bullimore, R Rampling, JT Roberts, M Glaser, P Lantos, JW Ironside, TH Moss, M Brada, JB Whaley and SP Stenning for the MRC Brain Tumour Working Party (). A Medical Research Council Randomised Trial in patients with primary cerebral non-Hodgkin lymphoma. Cancer 89(6): 1359-1370 | 15/09/2000 | Yes | No |
