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ISRCTN
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ISRCTN65282717
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DOI
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10.1186/ISRCTN65282717
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ClinicalTrials.gov identifier
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NCT00002490
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EudraCT number
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Public title
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A randomised trial of radical radiotherapy in pT1g3 NXM0 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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BS06
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Study hypothesis
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1. To determine the efficacy of radical radiotherapy in reducing the incidence of progression of pT1G3 transitional cell carcinoma of the bladder to muscleinvasive disease and subsequent disease fatality.
2. To assess the toxicity of the radiotherapy.
3. To determine the incidence of carcinoma in situ elsewhere in the bladder and the influence of this on the subsequent clinical outcome.
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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. A new diagnosis of pT1G3 NXMO tumour or tumours made within 6 months of randomisation. (A prior history of bladder tumours of a lower stage or grade is admissible)
2. No history of urothelial tumours of a higher stage
3. Muscle from the base of tumour is histologically clear
4. Widespread Carcinoma In Situ (CIS) causing severe symptoms is not admissible
5. No clinical, radiological or biochemical evidence of distant metastases
6. No prior therapy with intravesical chemotherapy or BCG other than a single adjuvant treatment
7. No concomitant or previous malignancy other than non-melanomatous skin cancer or cervical intraepithelial neoplasia (CIN)
8. WHO performance status of 0-2
9. Complete resection of all tumours
10. Deemed suitable to undergo radiotherapy and cystoscopy follow-up
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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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01/09/1991
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Anticipated end date
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30/04/2003
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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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200
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Interventions
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1. One group receives radical radiotherapy
2. The other group receives intravesical treatment with no radiotherapy
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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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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. Harland SJ: A randomised trial of radical radiotherapy in pT1G3 NXM0 bladder cancer (MRC BS06). [Abstract] J Clin Oncol 23 (Suppl 16): A-4505, 379s, 2005.
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17631326
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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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06/04/2000
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Last edited
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04/09/2009
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Date ISRCTN assigned
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06/04/2000
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