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Standardisation of breast radiotherapy (START) trial
ISRCTN ISRCTN59368779
DOI 10.1186/ISRCTN59368779
ClinicalTrials.gov identifier NCT00005588
EudraCT number
Public title Standardisation of breast radiotherapy (START) trial
Scientific title
Acronym START
Serial number at source G9600656
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Added 30 July 2008: South East London (MREC 98/96) - approved 30/09/1998
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Breast cancer
Participants - inclusion criteria 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
Participants - exclusion criteria Patients requiring axillary radiotherapy after greater than a level 1 axillary dissection or after greater than 10 lymph nodes have been removed
Anticipated start date 01/01/1999
Anticipated end date 24/10/2002
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 4451 patients recruited up to 24/10/2002. 5 years follow up
Interventions Radiotherapy schedules using fraction sizes larger than 2.0 Gy
Primary outcome measure(s) 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.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding 1. Department of Health
2. Medical Research Council (UK)
3. Cancer Research UK
Trial website http://www.icr.ac.uk/research/research_sections/clinical_trials/clinical_trials_list/2414_disease.shtml
Publications 1. March 2008 results on 'Trial A' in http://www.ncbi.nlm.nih.gov/pubmed/18355913
2. April 2008 results on 'Trial B' in http://www.ncbi.nlm.nih.gov/pubmed/18356109
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20138809
Contact name Prof  John  Yarnold
  Address Department of Radiotherapy
Royal Marsden Hospital
The Institute of Cancer Research
Downs Road
  City/town Sutton
  Zip/Postcode SM2 5PT
  Country United Kingdom
Sponsor Institute of Cancer Research (UK)
  Address 123 Old Brompton Road
  City/town London
  Zip/Postcode SW7 3RP
  Country United Kingdom
  Sponsor website: http://www.icr.ac.uk
Date applied 06/04/2000
Last edited 02/02/2012
Date ISRCTN assigned 06/04/2000
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