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ISRCTN
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ISRCTN69711558
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DOI
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10.1186/ISRCTN69711558
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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 carboplatin based combination chemotherapy for good prognosis metastatic malignant teratoma
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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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TE09
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Study hypothesis
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To define equivalent activity and lower toxicity of combination chemotherapy containing carboplatin rather than cisplatin
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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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Histologically confirmed non-seminomatous germ cell tumour of testis or combined seminoma/teratoma or seminoma with unequivocal raised serum alpha feto protein concentration
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Participants - exclusion criteria
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Previous chemotherapy.
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Anticipated start date
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01/06/1989
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Anticipated end date
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31/12/1993
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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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450
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Interventions
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Arm 1 - 4 cycles BEP.
Arm 2 - 4 cycles CEB.
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Primary outcome measure(s)
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Complete remission on chemotherapy or chemotherapy + surgery. Progression-free survival. Survival, toxicity.
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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 on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=9164194
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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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11/09/2007
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Date ISRCTN assigned
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28/02/2001
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