START

Disease site: Breast Cancer

Treatment Modality: Radiotherapy

Status: In active follow-up

The trial compares regimens with fraction sizes >2Gy with the "standard" 50Gy in 25 fractions. Recruitment to the trial closed at the end of October 2002 18 months ahead of schedule. A total of 4451 patients have been entered from 34 centres. The associated studies of quality of life, photographic assessments, blood sampling and family history have also recruited successfully. The trial provides unique systematic data on the characteristics of breast cancer patients allocated radiotherapy in the UK. The quality of life study represents the largest UK data set for this patient group and provides a valuable reference set for future comparisons and to establish the quality of life for women who received surgical and systemic treatments for early breast cancer prior to breast radiotherapy. Further funding was received in 2002 to cover the required minimum of 5 years' follow-up and the analysis and writing-up of the trial.

The START trial results have been published in Lancet and Lancet Oncology:
1. START Trialists' Group, 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). The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncology 2008 Apr;9(4):331-341. Epub 2008 Mar 19

2. START Trialists' Group, 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). The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet 2008 Mar 29;371(9618):1098-1107. Epub 2008 Mar 19

The START trial QL results have been published in Lancet Oncology:
3. Penelope Hopwood, Joanne S Haviland, Georges Sumo, Judith Mills, Judith M Bliss, John R Yarnold, on behalf of the START Trial Management Group (2010). 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. Lancet Oncology Published online February 8, 2010