Contact information
Type
Scientific
Contact name
Miss Sally Stenning
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
ss@ctu.mrc.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
BR06
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effect of CHOP chemotherapy on event-free and overall survival.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
CHOP chemotherapy
Primary outcome measure
Survival.
Secondary outcome measures
Event-free survival.
Overall study start date
01/11/1988
Overall study end date
01/10/1995
Reason abandoned (if study stopped)
Slow accrual
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
75 Years
Sex
Not Specified
Target number of participants
Target: 90, accrued: 53
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/1988
Recruitment end date
01/10/1995
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |