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ISRCTN
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ISRCTN53643604
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ClinicalTrials.gov identifier
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NCT00301782
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Public title
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Randomised phase II trial comparing intensive induction chemotherapy (CBOP BEP) with standard BEP chemotherapy in poor prognosis male germ cell tumours
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Scientific title
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Acronym
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TE23
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Serial number at source
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MRC TE23 Study, Version 1.0
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Study hypothesis
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Not provided at time of registration
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Lay summary
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http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=38
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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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Male non-seminoma germ cell tumours (NSGCT)
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Participants - inclusion criteria
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1. Non-seminomatous germ cell tumour of any extracranial primary site
2. Poor prognonsis features, as defined by International Germ Cell Cancer Collaborative Group (IGCCCG) criteria
3. Performance status 0 - 3
4. Globular filtration rate greater than 50 ml/min
5. No comorbid condition
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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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01/06/2005
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Anticipated end date
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01/06/2010
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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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88
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Interventions
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Patients will be randomly allocated either the 'gold standard' BEP (bleomycin, etoposide and cisplatin) chemotherapy or the intensive induction regimen CBOP/BEP (carboplatin, bleomycin, vincristine, cisplatin, etoposide).
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Primary outcome measure(s)
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Not provided at time of registration
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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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Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC)
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Trial website
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Publications
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Contact name
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Dr
Robert
Huddart
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Address
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Institute of Cancer Research and Royal Marsden Hospital
Downs Road
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City/town
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Sutton
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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c/o Dr Ian Viney
MRC Centre London
Stephenson House
158-160 North Gower Street
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City/town
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London
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Zip/Postcode
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NW1 2ND
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Country
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United Kingdom
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Sponsor website:
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http://www.centre-london.mrc.ac.uk/
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Date applied
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11/08/2004
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Last edited
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02/08/2011
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Date ISRCTN assigned
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22/10/2004
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