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ISRCTN
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ISRCTN77275134
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DOI
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10.1186/ISRCTN77275134
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A study of radiotherapy with or without chemotherapy in primary central nervous system (CNS) lymphoma
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Scientific title
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Acronym
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N/A
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Serial number at source
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BR06
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Study hypothesis
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To evaluate the effect of CHOP chemotherapy on event-free and overall survival.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer
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Participants - inclusion criteria
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1. Pathologically proven primary cerebral lymphoma
2. Aged 18-75
3. No previous radiotherapy or chemotherapy
4. Adequate neurological, physical and mental function
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/11/1988
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Anticipated end date
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01/10/1995
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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Target: 90, accrued: 53
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Interventions
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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)
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Primary outcome measure(s)
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Survival.
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Secondary outcome measure(s)
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Event-free survival.
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 1998 ASCO Annual Meeting abstract results in http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=31&abstractID=13720
2. 2000 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 (2000). A Medical Research Council Randomised Trial in patients with primary cerebral non-Hodgkin lymphoma. Cancer 89(6): 1359-1370 in http://www.ncbi.nlm.nih.gov/pubmed/11002232
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Contact name
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Miss
Sally
Stenning
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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ss@ctu.mrc.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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28/02/2001
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Last edited
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29/07/2009
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Date ISRCTN assigned
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28/02/2001
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