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ISRCTN
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ISRCTN77353795
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DOI
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10.1186/ISRCTN77353795
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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 epirubicin versus mitomycin C at the time of first recurrence in superficial bladder 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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BS07
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Study hypothesis
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1. To detect the reduction, if any, in recurrence following irrigation of the bladder with glycine or saline for a minimum of 18 hours after complete resection of newly-diagnosed superficial bladder cancer.
2. To compare the effect of Mitomycin C against Epodyl in preventing further recurrence in patients who have developed a recurrent superficial tumour after the initial transurethral resection.
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Lay summary
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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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Bladder cancer
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Participants - inclusion criteria
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1. Newly-diagnosed superficial carcinoma of bladder suitable for complete endoscopic resection, limited to the bladder
2. World Health Organisation (WHO) status zero to two
3. Expected survival at least three years
4. No history of other malignant tumours, except non-melanomatous skin tumours, or carcinoma in-situ (CIN)
5. No untreated urinary tract infection (UTI)
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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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22/04/1994
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Anticipated end date
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01/01/1998
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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800
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Interventions
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First randomisation is between irrigation of the bladder with glycine/saline and no irrigation.
The second randomisation is between Epodye and mitomycin C.
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Primary outcome measure(s)
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Local recurrence, time to progression, metastases, morbidity
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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 (MRC) (UK)
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Trial website
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Publications
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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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28/02/2001
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Last edited
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07/06/2012
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Date ISRCTN assigned
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28/02/2001
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