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ISRCTN
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ISRCTN59368779
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ClinicalTrials.gov identifier
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Public title
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Standardisation of breast radiotherapy (START) trial
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Scientific title
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Acronym
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START
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Serial number at source
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G9600656
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Study hypothesis
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To test the effects of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, loco-regional tumour control, quality of life and economic consequences in women prescribed postoperative radiotherapy for early breast cancer.
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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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Breast cancer
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Participants - inclusion criteria
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1. Patients must be 18 years and above, have operable unilateral breast cancer (T1-3, NO-1, MO at presentation)
2. There must be histological confirmation of invasive carcinoma and complete macroscopic excision of tumour by breast conserving surgery or mastectomy
3. The patient must consent to be part of the study and be available for follow-up
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Participants - exclusion criteria
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Patients requiring axillary radiotherapy after greater than a level 1 axillary dissection or after greater than 10 lymph nodes have been removed
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Anticipated start date
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01/01/1999
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Anticipated end date
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31/10/2008
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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4451 patients recruited up to Oct 2002. 5 years follow up
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Interventions
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Radiotherapy schedules using fraction sizes larger than 2.0 Gy
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Primary outcome measure(s)
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In this study several endpoints are being investigated (tumour recurrence, normal tissue effect, quality of life). It is intended that each will be analysed separately. If there is discordance between the endpoints in terms of treatment outcome this will allow discussion of clinical trade-offs. In a subset of patients there will be a detailed assessment of quality of life. Health economic consequences will also be determined.
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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:
1. http://www.ncbi.nlm.nih.gov/pubmed/18355913
2. http://www.ncbi.nlm.nih.gov/pubmed/18356109
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Contact name
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Prof
John
Yarnold
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Address
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Department of Radiotherapy
Royal Marsden Hospital
The Institute of Cancer Research
Downs Road
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City/town
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Sutton, Surrey
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Zip/Postcode
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SM2 5PT
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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 (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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15/04/2008
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Date ISRCTN assigned
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06/04/2000
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