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ISRCTN
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ISRCTN59482963
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ClinicalTrials.gov identifier
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Public title
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To Compare Intravenous Treosulphan with Intravenous Treosulphan plus Cisplatin in Advanced 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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O10
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Study hypothesis
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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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Ovarian cancer
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Participants - inclusion criteria
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1. International Federation of Gynecology and Obstetrics (FIGO) stage Ic or II (except well differentiated), III or IV ovarian cancer
2. Histological confirmation of carcinoma of epithelial origin
3. Aged 75 or under
4. Life expectancy >2 months
5. No extensive prior chemotherapy (no prior treosulfan or cisplatin at all, and not more than one course of other cytotoxic treatment)
6. No radical prior radiotherapy to pelvis and/or abdomen within preceding 3 months
7. No depressed marrow function or gastro-intestinal bleeding
8. Good renal function
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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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01/01/1993
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Anticipated end date
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01/08/1995
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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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Not provided at time of registration
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Interventions
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Patients are randomised to one of two treatment arms:
1. Arm A: Treosulphan given every 3 weeks
2. Arm B: Treosulphan plus cisplatin repeated every 3 weeks
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Primary outcome measure(s)
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Not provided at time of registration
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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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Leo Pharmaceuticals (UK)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
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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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Leo Pharmaceuticals (UK)
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Address
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Longwick Road
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City/town
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Princes Risborough
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Zip/Postcode
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HP27 9RR
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Country
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United Kingdom
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Tel
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+44 (0) 1844 347333
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Email
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Sponsor website:
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http://www.leo-pharma.co.uk/w-site/leo-gb/docs-gb.nsf
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Date applied
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19/08/2002
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Last edited
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27/05/2008
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Date ISRCTN assigned
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19/08/2002
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