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ISRCTN
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ISRCTN48397858
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ClinicalTrials.gov identifier
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Public title
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A randomised trial of maintenance weekly paclitaxel versus observation following remission with first-line induction carboplatin and paclitaxel for patients 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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PACMAIN
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Study hypothesis
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It is intended that this study will run in the UK, mainland Europe and Australasia. If the study proves positive, it will require confirmation and will raise the question of whether weekly paclitaxel given for longer periods maybe even more effective.
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Ethics approval
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No ethics information required 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, Australasia, Europe
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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, fallopian tube cancer and primary peritoneal cancer
2. Female, aged 18 years and over
3. International Federation of Gynecology and Obstetrics (FIGO) stage III to IV. Receive six cycles of carboplatin/paclitaxel, three-weekly at registration
4. Able to complete quality of life questionnaires
5. Can comply with follow-up requirements. Written informed consent
6. Response to induction treatment (as demonstrated by a Computed Tomography [CT] scan)
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Participants - exclusion criteria
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1. Patients with peritoneal carcinomatosis of 'uncertain' origin which is mucin-secreting
2. Histological evidence of an origin in the gastrointestinal tract, bilary system or lung
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Anticipated start date
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16/12/2002
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Anticipated end date
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01/03/2005
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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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1200
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Interventions
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Maintenance chemotherapy: paclitaxel 70 mg/m^2 weekly, beginning three weeks after the last cycle of carboplatin/paclitaxel induction therapy and continuing for 15 weeks.
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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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Not provided at time of registration
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Sources of funding
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The Institute of Cancer Research (UK)
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Trial website
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Publications
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Contact name
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Prof
Martin
Gore
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Address
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Skin & Melanoma Unit
Royal Marsden NHS Foundation Trust
Fulham Road
Chelsea
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City/town
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London
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Zip/Postcode
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SW3 6JJ
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Country
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United Kingdom
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Sponsor
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The Institute of Cancer Research (UK)
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Address
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123 Old Brompton Road
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City/town
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London
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Zip/Postcode
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SW7 3RP
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Country
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United Kingdom
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Tel
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+44(0) 20 7352 8133
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Fax
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+44(0) 20 7370 5261
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Email
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Sponsor website:
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http://www.icr.ac.uk
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Date applied
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15/10/2002
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Last edited
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06/08/2009
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Date ISRCTN assigned
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15/10/2002
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