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ISRCTN
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ISRCTN82138783
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ClinicalTrials.gov identifier
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Public title
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A Trial of Accelerated Fractionation in Localised Invasive 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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ICR/CUCG
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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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Bladder (advanced)
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Participants - inclusion criteria
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1. Stage T2 or T3 NXMO carcinoma of the bladder defined either by clinical findings or by histopathology
2. If nodes are assessed N1 patients (single node <2 cm) are eligible, N2 and N3 patients are excluded
3. Patients with severe concurrent general medical illness especially those with inflammatory bowel disease, other malignancies (except skin cancer), recent myocardial infarction (within 3 months) or previous major pelvic surgery are excluded
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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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01/01/1988
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Anticipated end date
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31/12/1998
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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. Schedule A: Radiotherapy, an accelerated fractionation schedule of 60.8 Gy given in thirty-two fractions over 26 days. Radiotherapy is given twice daily (morning dose of 1.8 Gy and 2.0 Gy in the afternoon) as 22.8 Gy in twelve fractions over 8 days, followed by a 3 to 6 day gap, followed by 38 Gy in twenty fractions over 2 weeks.
2. Schedule B: Radiotherapy, a conventional fractionation schedule of 64 Gy given in thirty-two fractions over 6.5 weeks. Radiotherapy is given once per day 5 days per week.
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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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Institute of Cancer Research (UK)
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Trial website
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Publications
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2005 results on http://www.ncbi.nlm.nih.gov/pubmed/15878099
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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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The Institute of Cancer Research (UK)
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Address
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123 Old Brompton Road
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City/town
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London
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Zip/Postcode
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SW7 3RP
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Country
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United Kingdom
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Tel
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+44(0) 20 7352 8133
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Fax
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+44(0) 20 7370 5261
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Email
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Sponsor website:
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http://www.icr.ac.uk
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Date applied
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19/08/2002
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Last edited
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19/05/2008
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Date ISRCTN assigned
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19/08/2002
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