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ISRCTN
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ISRCTN79658966
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DOI
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10.1186/ISRCTN79658966
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Study of chemotherapy for patients with good prognosis metastatic non-seminomatous testicular 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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TE03
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Study hypothesis
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Investigate whether the toxicity of chemotherapy in patients with small volume metastasis and low blood marker concentrations can be decreased by the reduction of the dose of Bleomycin given in the BEP regimen without loss of therapeutic activity.
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Lay summary
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Not provided at time of registration
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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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Histologically proven non-seminomatous testicular cancer
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Participants - exclusion criteria
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Previous radiotherapy or chemotherapy
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Anticipated start date
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01/01/1986
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Anticipated end date
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31/12/1986
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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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44
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Interventions
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Arm 1: Bleomycin 30 mg x 3 per course, BEP x 4
Arm 2: Bleomycin 30 mg per course, BEP x 4
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Primary outcome measure(s)
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Toxicity/response
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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 (MRC) (UK)
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Trial website
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Publications
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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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20/07/2012
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Date ISRCTN assigned
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28/02/2001
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