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ISRCTN
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ISRCTN61145589
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ClinicalTrials.gov identifier
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Public title
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SUPREMO, an MRC Phase III randomised trial to assess the role of adjuvant chest wall irradiation in 'intermediate risk' operable breast cancer following mastectomy
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Scientific title
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Acronym
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SUPREMO
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Serial number at source
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G0400170
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Study hypothesis
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To determine the effect of ipsilateral chest wall irradiation following mastectomy and axillary clearance for women with operable breast cancer at 'intermediate risk' of loco-regional recurrence.
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Lay summary
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http://www.cancerhelp.org.uk/trials/a-trial-looking-at-the-benefit-of-radiotherapy-after-mastectomy-for-breast-cancer
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Ethics approval
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Fife and Forth Valley Research Ethics Committee on 04/10/2005. (ref:05/S0501/106)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia, United Kingdom, Europe, International
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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. pT1, pN1, M0 or pT2, N0-1, M0 unilateral histologically confirmed invasive breast cancer
2. Unifocal invasive breast cancer
3. Fit for adjuvant therapy, adjuvant endocrine therapy and postoperative irradiation
4. Undergone simple mastectomy and an axillary staging procedure
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Participants - exclusion criteria
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1. Undergone neoadjuvant systemic therapy
2. Previous or concurrent malignancy
3. Male sex
4. Pregnancy
5. Bilateral breast cancer
6. Known BCRA1 and BCRA2 carriers
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Anticipated start date
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01/10/2005
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Anticipated end date
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28/11/2014
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Status of trial
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Ongoing |
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Patient information material
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Patient information can be found at: http://www.supremo-trial.com/Summary%20Of%20Trial.html
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Target number of participants
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3700
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Interventions
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Chest wall irradiation versus no chest wall irradiation
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Primary outcome measure(s)
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Overall survival
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Secondary outcome measure(s)
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Disease free survival
Metastasis free survival
Cause of death
Acute and late morbidity
Quality of Life
Cost effectiveness
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Sources of funding
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Medical Research Council (UK) (G0400170)
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Trial website
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http://www.supremo-trial.com
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Publications
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2006 Lancet publication in http://www.ncbi.nlm.nih.gov/pubmed/16714179
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Contact name
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Prof
Ian
Kunkler
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Address
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Edinburgh Cancer Centre
Western General Hospital
Crewe Road
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City/town
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Edinburgh
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Zip/Postcode
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EH4 2XU
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Country
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United Kingdom
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Tel
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+44 (0)131 537 2214
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Fax
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+44 (0)131 537 2216
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Email
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i.kunkler@ed.ac.uk
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Sponsor
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University of Edinburgh, Lothian Health Board and the Common Services Agency (UK)
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Address
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Dr Douglas Young MBA
Commercial Research Manager
Research and Development Office
NHS Lothian-University Hospitals Division
The Royal Infirmary of Edinburgh
51 Little France Crescent
Old Dalkeith Road
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City/town
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Edinburgh
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Zip/Postcode
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EH16 4SA
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Country
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United Kingdom
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Date applied
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23/06/2005
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Last edited
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02/08/2011
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Date ISRCTN assigned
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29/07/2005
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