Standardisation of breast radiotherapy (START) trial

Conditions

Breast cancer Cancer Breast cancer

Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR, START Trialists' Group.

2013-09-19964 citations

10.1016/s1470-2045(13)70386-3

Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials.

Hopwood P, Haviland JS, Sumo G, Mills J, Bliss JM, Yarnold JR, START Trial Management Group.

2010-02-06151 citations

10.1016/s1470-2045(09)70382-1

The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial.

START Trialists' Group, Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR.

2008-03-19770 citations

10.1016/s0140-6736(08)60348-7

The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial.

START Trialists' Group, Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR.

2008-03-19723 citations

10.1016/s1470-2045(08)70077-9

Interventions

Radiotherapy schedules using fraction sizes larger than 2.0 Gy

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria: Patients requiring axillary radiotherapy after greater than a level 1 axillary dissection or after greater than 10 lymph nodes have been removed

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Not provided at time of registration	—

Countries

England, United Kingdom

Outcome results

None listed