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ISRCTN
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ISRCTN84121653
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DOI
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10.1186/ISRCTN84121653
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ClinicalTrials.gov identifier
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NCT00003695
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EudraCT number
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Public title
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A randomised trial of interval debulking surgery in epithelial ovarian cancer suboptimally debulked at primary surgery
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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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OV06
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Study hypothesis
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To determine the impact of interval debulking surgery in newly diagnosed ovarian cancer in patients with residual macroscopic disease after surgery.
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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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1. Newly diagnosed, histologically confirmed epithelial ovarian cancer
2. International Federation of Gynecology and Obstetrics (FIGO) stage II, III or IV
3. Residual macroscopic disease more than 1 cm in diameter documented at primary surgery or post-operatively by imaging
4. Patient planned to receive platinum-based chemotherapy
5. Patient fit for interval debulking surgery
6. No concomitant or previous malignancy likely to interfere with protocol treatments or comparisons
7. Written informed consent
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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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01/04/1998
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Anticipated end date
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26/07/2001
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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1000
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Interventions
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One group interval debulking surgery/control
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Primary outcome measure(s)
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Survival, progression-free survival and quality of life
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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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Ms
Sarah
Wheeler
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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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06/04/2000
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Last edited
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06/06/2012
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Date ISRCTN assigned
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06/04/2000
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