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ISRCTN
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ISRCTN14535482
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DOI
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10.1186/ISRCTN14535482
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Treatment of poor prognosis metastatic 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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TE13
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Study hypothesis
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Determine whether treatment with the intensive regimen BOP/VIP-B is more effective than BEP/P.
To determine the effect of G-CSF on the proportion of patients receiving full dose intensity of combination chemotherapy with either regimen.
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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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Metastatic teratoma
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Participants - inclusion criteria
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Histologically proven non-seminomatous germ cell tumour
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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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01/02/1991
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Anticipated end date
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31/12/1994
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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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154
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Interventions
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Arm 1 - Without granulocyte colony stimulating factor (G-CSF), BEP/EP.
Arm 2 - Without G-CSF, BOP/VIP-B.
Arm 3 - With G-CSF, BEP/EP.
Arm 4 - With G-CSF, BOP/VIP-B.
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Primary outcome measure(s)
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Progression-free survival
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Secondary outcome measure(s)
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Response rate, overall 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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Contact name
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Miss
Sharon
Naylor
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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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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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31/01/2013
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Date ISRCTN assigned
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28/02/2001
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