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ISRCTN
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ISRCTN62526210
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ClinicalTrials.gov identifier
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Public title
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The role of radical surgery in advanced epithelial 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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OV3006
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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. Histologically confirmed epithelial ovarian cancer
2. Macroscopic residual disease unlikely in surgeon's opinion to be completely debulked without bowel resection or other procedures
3. No attempt to radically debulk
4. No prior chemotherapy or radiotherapy
5. No previous or concurrent malignancy other than non melanomatous skin cancer
6. No haematological or biochemical contra-indication to platinum chemotherapy
7. No contraindication to second laparotomy
8. Available to commence chemotherapy or undergo further surgery within 6 weeks of diagnostic laparotomy
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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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01/01/1990
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Anticipated end date
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31/12/1995
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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: High activity platinum based chemotherapy. The recommended chemotherapy regimen is cyclophosphamide and cisplatin given for a maximum of eight cycles.
2. Arm B: Radical debulking surgery followed by chemotherapy as described above.
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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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Cancer Research 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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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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27/05/2008
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Date ISRCTN assigned
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01/07/2001
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