§ Lord Ironsideasked Her Majesty's Government:
(a) how many of the 53 United Kingdom radiotherapy treatment centres are participating in the Standards in Radiotherapy (START) trial; (b) what are the objectives of the trial; and (c) whether the objectives of the trial should be reassessed in view of the very low dose in two fractions per day regime now being adopted in Germany by some expert radiotherapists as being the most efficacious and safest treatment regime. [HL3864]
§ Lord Sainsbury of TurvilleThe MRC is supporting the UKCCCR standardisation of breast radiotherapy (START) clinical trial.
(a) Thirty-seven of the UK radiotherapy centres have expressed an interest in participating in the START trial. Twenty-three of these 37 centres are already recruiting patients and a further nine have local research ethics committee approval.
(b) The objectives of the trial are to test the effects of radiotherapy schedules using fraction sizes larger than 2.0Gy in terms of normal tissue response, loco-regional tumour control, quality of life and economic consequences in women prescribed postoperative radiotherapy for early breast cancer.
(c) There is considerable variability in radiotherapy regimes used to treat breast cancer in Germany, North America and Europe and no widely accepted method. One of the commonest regimes is 2Gy per day, and this is one of the regimes in the START trial. There is no evidence that this is the optimal fractionation regime and there is a need for prospective good quality comparative data, comparing this with other regimes for both local control rates and short and long term morbidity to establish best practice in the area. This is the purpose of the START trial.