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ISRCTN
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ISRCTN82694463
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DOI
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10.1186/ISRCTN82694463
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A phase III study of primary chemotherapy in T2 (G3), T3 and T4a; N0 or NX; M0 transitional cell carcinoma (TCC) of the bladder
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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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BA06
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Study hypothesis
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1. To determine the survival advantage of the addition of three cycles of cisplatin, methotrexate,and vinblastine (CMV) chemotherapy prior to definitive radiotherapy and/or cystectomy
2. To determine the morbidity and mortality of definitive treatment together with any additional toxicity, arising from CMV chemotherapy
3. To determine the prognostic significance of downstaging to T0 following CMV chemotherapy
Collaboration with the European Organization for Research and Treatment of Cancer (EORTC), Australian Bladder Cancer Study Group. Norwegian Bladder Cancer Study Group, Club Urologico Espanol de Tratamiento Group, Finnbladder and National Cancer Institute, Canada
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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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International
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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. Histologically proven TCC of the bladder with biopsy proven muscle invasion
2. Tumours considered curable (less than or equal to 7 cm)
3. GFK ≥50 ml/min (Cockcroft)
4. White blood count (WBC) >3.5 x 10^9/L and platelet count >100 x 10^9/L
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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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01/12/1989
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Anticipated end date
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10/07/1995
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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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915 required, 975 entered
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Interventions
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Primary chemotherapy in T2 (G3), T3 and T4a; N0 or NX; M0 TCC of the bladder
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Primary outcome measure(s)
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Survival
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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. 1999 results on http://www.ncbi.nlm.nih.gov/pubmed/10470696.
2. Hall RR, on behalf of the International Collaboration of the MRC Advanced Bladder Cancer Group. Updated results of a randomised control trial of neo-adjuvant cisplatin(C) methotrexate(M) and Vinblatine(V) Chemotherapy for muscle-invasive bladder cancer. Proceedings of ASCO, Vol 21, Abstract 710, 2002.
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Contact name
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Dr
Barbara
Uscinska
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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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20/08/2009
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Date ISRCTN assigned
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13/03/2001
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