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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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7 November 2022 |
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Main ID: |
ISRCTN59368779 |
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Date of registration:
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06/04/2000 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Standardisation of breast radiotherapy (START) trial |
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Date of first enrolment:
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01/01/1999 |
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Target sample size:
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4451 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN59368779 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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England
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United Kingdom
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Contacts
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Name:
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John
Yarnold |
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Address:
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Department of Radiotherapy
Royal Marsden Hospital
The Institute of Cancer Research
Downs Road
SM2 5PT
Sutton
United Kingdom |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: Patients requiring axillary radiotherapy after greater than a level 1 axillary dissection or after greater than 10 lymph nodes have been removed
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast cancer
Cancer
Breast cancer
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Intervention(s)
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Radiotherapy schedules using fraction sizes larger than 2.0 Gy
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Primary Outcome(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(s)
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Not provided at time of registration
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Secondary ID(s)
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NCT00005588
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G9600656
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Source(s) of Monetary Support
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Department of Health, Medical Research Council (UK), Cancer Research UK
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Ethics review
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Status:
Approval date:
Contact:
Added 30 July 2008: South East London (MREC 98/96) - approved 30/09/1998
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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24/10/2002 |
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URL:
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