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START

Standardisation of breast radiotherapy trial.

Disease site: Breast cancer

Treatment modality: Radiotherapy

Status: In active follow-up

Trial details

The national Standardisation of Radiotherapy (START) Trial in breast cancer was launched in January 1999 and aimed to identify the optimal regimen in terms of tumour control, late normal tissue effects and patient-reported quality of life, and to standardise routine radiotherapy treatments throughout the NHS for women with early breast cancer.

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 4,451 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.

Chief Investigator: Professor John Yarnold, Royal Marsden NHS Foundation Trust and The Institute of Cancer Research

ICR-CTSU Scientific Lead: Professor Judith Bliss

Trial management contact: Mark Sydenham - Trial Manager, [email protected]

ISRCTN: 59368779

Sponsor: The Royal Marsden NHS Foundation Trust

Funding: DoH, MRC & Cancer Research UK (CRUK/96/001)

Publications and presentations

Over 60 publications and presentations have been generated by the START trial to date, including:

The START Trialists Group. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lanc. Oncol. 2008;Apr; 9(4):331-41

The START Trialists Group. The UK Standardisation of Breast radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet 2008;371:1098-107

Hopwood P, Sumo G, Mills J, Haviland J, Bliss JM, Yarnold J, on behalf of the START Trial Management Group. Patient rated breast symptoms and body image in early breast cancer: first results of the UK standardisation of breast radiotherapy (START) trials. Br Canc Res & Treatment 2007;106(Suppl 1):S199 #4097

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.