Standardisation of breast radiotherapy (START) trial

Not Applicable

Completed

• Conditions: Breast cancer; Cancer

• Registration Number: ISRCTN59368779
• Lead Sponsor: Institute of Cancer Research (UK)

Brief Summary

2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18355913 March results on 'Trial A' 2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18356109 April results on 'Trial B' 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20138809 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-04-06
• Study Completion: 2002-10-24
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 4451

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
ot provided at time of registration