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ISRCTN
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ISRCTN27785591
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ClinicalTrials.gov identifier
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Public title
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A randomised trial of combination bleomycin, ifosfamide and cisplatinum versus single agent cisplatinum in recurrent cervical 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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CE3004
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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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Cervix
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Participants - inclusion criteria
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1. Histologically proven recurrent invasive squamous cell carcinoma of the cervix uteri
2. Symptomatic inoperable pelvic or metastatic disease not amenable to local radiotherapy
3. No previous chemotherapy with any of the study agents
4. World Health Organisation (WHO) performance status >2
5. Adequate renal hepatic and haematological function
6. Adequate pulmonary function
7. Expected survival of >3 months
8. No second primary tumour other than basal cell carcinoma of the skin
9. No other serious medical or psychological condition precluding treatment
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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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28/02/1996
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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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1. Arm A: Chemotherapy with single agent cisplatinum repeated every 21 days for a maximum of six courses.
2. Arm B: Multi-drug chemotherapy with bleomycin, ifosfamide and cisplatinum (BIP) repeated every 21 days for a maximum of six courses.
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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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31/01/2008
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Date ISRCTN assigned
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01/07/2001
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