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ISRCTN
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ISRCTN77165120
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ClinicalTrials.gov identifier
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Public title
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Randomized phase III trial of paclitaxel plus topotecan versus topotecan plus cisplatin in recurrent or persistent cervical cancer stage IVb
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Scientific title
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Acronym
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AGO-Uterus-9
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Serial number at source
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IFG-01-0106
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Study hypothesis
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A chemotherapy scheme with topotecan and paclitaxel can be equally or more effective in advanced cervical cancer as a standard chemotherapy scheme
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Lay summary
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Ethics approval
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Ethics approval details not yet received as of 15/05/2006
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Study design
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Prospective, two-armed, randomised clinical therapy trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Advanced carcinoma of the cervix uteri
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Participants - inclusion criteria
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Patients with progressive histologically confirmed carcinoma of the cervic uteri and measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) without treatment alternatives to chemotherapy
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Participants - exclusion criteria
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Bilateral hydronephrosis, central nervous system (CNS)-metastases or reduced general condition
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Anticipated start date
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01/02/2006
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Anticipated end date
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31/01/2008
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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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326
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Interventions
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Patients are randomised to receive one of the following:
1. Paclitaxel and topotecan
2. Topotecan and cisplatin
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Primary outcome measure(s)
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Overall-survival
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Secondary outcome measure(s)
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1. Time to progression
2. Efficacy
3. Therapy tolerance
4. Quality of life
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Sources of funding
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Institute for Women’s Health budget supported by GlaxoSmithKline GmbH & Co. KG Germany
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Trial website
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Publications
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Contact name
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Prof
Matthias W.
Beckmann
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Address
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Universitaetsstr. 21-23
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City/town
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Erlangen
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Zip/Postcode
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91054
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Country
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Germany
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Tel
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+49 (0)9131 8533451
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Fax
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+49 (0)9131 8533456
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Email
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studienzentrale@gyn.imed.uni-erlangen.de
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Sponsor
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Institute for Women’s Health (Institut fuer Frauengesundheit GmbH) (Germany)
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Address
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Universitaetsstr. 21-23
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City/town
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Erlangen
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Zip/Postcode
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91054
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Country
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Germany
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Tel
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+49 (0)9131 8533508
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Fax
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+49 (0)9131 8533938
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Email
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studienzentrale@gyn.imed.uni-erlangen.de
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Sponsor website:
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http://www.ifg-erlangen.de
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Date applied
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23/01/2006
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Last edited
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15/05/2006
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Date ISRCTN assigned
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15/05/2006
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