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ISRCTN
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ISRCTN35399995
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ClinicalTrials.gov identifier
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Public title
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Treatment of good prognosis germ cell cancer
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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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TE20
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Study hypothesis
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To compare 3 x BEP and 3 x BEP + 1 x EP and the five day schedule versus three days per cycle in good prognosis germ cell cancer
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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. Seminoma or non-seminoma - testis or retroperitoneal primary, alpha-fetoprotein (AFP) ≤1000 iu/l human chorionic gonadotrophin (HCG) ≤5000 iu/l, lactic dehydrogenase (LDH) ≤1.5 x N
2. No liver, bone or brain mets seminoma - stage ≥2 C or relapse after radiotherapy and any primary site and LDH
3. No liver bone or brain mets
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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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01/05/1995
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Anticipated end date
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01/05/1998
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Status of trial
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Completed
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Patient information material
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Target number of participants
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800
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Interventions
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There are four groups:
1. The first receives three cycles of BEP chemotherapy over a five day schedule
2. The second group receives three cycles of BEP + 1 cycle of EP chemotherapy over a 5 day schedule
3. The third group receives three cycles of BEP over a 3 day schedule
4. The fourth group receives three cycles of BEP over a 3 day schedule plus one cycle of EP
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Primary outcome measure(s)
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Time to progression; Quality of life, Morbidity, Survival time
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=12637478
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11250991
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Contact name
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Mrs
Pat
Cook
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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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pat.cook@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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17/07/2007
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Date ISRCTN assigned
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28/02/2001
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