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ISRCTN
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ISRCTN57776460
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DOI
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10.1186/ISRCTN57776460
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised trial of intravesical thiotepa versus no intravesical chemotherapy
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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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BS01
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Study hypothesis
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1. To detect any effect of intravesical instillation of Thiotepa on the recurrence rate of superficial bladder cancer
2. To detect any extra effect of repeating instillations of Thiotepa at follow-up cytoscopy during the first year on the recurrence rate of superficial bladder cancer
3. To assess the effect of the presence of urothelial atypism or carcinoma in random biopsies on the recurrence rate of superficial bladder cancer
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Lay summary
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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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Cancer
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Participants - inclusion criteria
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1. Newly diagnosed superficial carcinoma of the bladder suitable for complete endoscopic resection
2. World Health Organisation (WHO) performance status 0-2
3. Expected survival at least 3 years
4. White count >3 x 10^9/L and platelets >100 x 10^9/L
5. No history of other malignant tumours
6. No untreated urinary tract infection
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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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01/10/1981
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Anticipated end date
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31/12/1991
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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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417
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Interventions
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Intravesical thiotepa versus no intravesical chemotherapy
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Primary outcome measure(s)
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1. Time to first superficial
2. Recurrence rate (number of positive cytoscopies per annum)
3. Failure-free survival rate
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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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Medical Research Council (UK)
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Trial website
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Publications
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Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=8032829
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Contact name
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Dr
Danielle
Andrews
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Address
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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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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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13/03/2001
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Last edited
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11/09/2007
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Date ISRCTN assigned
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13/03/2001
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