A study of radiotherapy with or without chemotherapy in primary central nervous system (CNS) lymphoma

ISRCTN ISRCTN77275134
DOI https://doi.org/10.1186/ISRCTN77275134
Secondary identifying numbers BR06
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

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email ss@ctu.mrc.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedCancer
InterventionGroup 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)CHOP chemotherapy
Primary outcome measureSurvival.
Secondary outcome measuresEvent-free survival.
Overall study start date01/11/1988
Completion date01/10/1995
Reason abandoned (if study stopped)Slow accrual

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexNot Specified
Target number of participantsTarget: 90, accrued: 53
Key inclusion criteria1. Pathologically proven primary cerebral lymphoma
2. Aged 18-75
3. No previous radiotherapy or chemotherapy
4. Adequate neurological, physical and mental function
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/1988
Date of final enrolment01/10/1995

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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