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ISRCTN
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ISRCTN47434271
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DOI
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10.1186/ISRCTN47434271
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ClinicalTrials.gov identifier
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NCT00002894
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EudraCT number
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Public title
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A randomised trial of paclitaxel combined with platinum-based chemotherapy vs conventional platinum-based chemotherapy in the treatment of women with ovarian 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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ICON4
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Study hypothesis
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To compare paclitaxel combined with platinum to a control arm of conventional platinum-based chemotherapy in the treatment of women with recurrent ovarian cancer.
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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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International
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Disease/condition/study domain
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Ovarian cancer
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Participants - inclusion criteria
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1. Recurrent epithelial ovarian cancer previously treated with chemotherapy
2. Treatment free interval of at least 6 months
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/03/1996
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Anticipated end date
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31/03/2002
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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 in 5 countries
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Interventions
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Paclitaxel combined with platinum and the other group receives platinum-based chemotherapy (with no paclitaxel)
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Primary outcome measure(s)
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1. Survival time
2. Quality of life
3. Health economics
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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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2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12826431
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Contact name
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Ms
Claire
Amos
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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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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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06/04/2000
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Last edited
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02/07/2009
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Date ISRCTN assigned
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06/04/2000
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