IMPORT LOW: Changing service delivery to optimise trial recruitment


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Mark Sydenham1, Judith Bliss1, Laura Ciurlionis3, Charlotte Coles2, Jo Haviland1, Jenny Titley1, John Yarnold1, IMPORT Trial Management Group4

1Institute of Cancer Research, Sutton, UK, 2Cambrodge University Hospitals NHS Foundation Trust, Cambridge, UK, 3Mount Vernon Hospital, Middlesex, UK, 4NHS, National, UK

Abstract

IMPORT LOW tests the benefits of partial breast radiotherapy in patients at lower than average risk of local tumour recurrence following breast conserving surgery.

Building on the successful network developed by the START and FAST trials we aim to open 35 UK radiotherapy centres and their referring centres, to recruit 1934 patients in a timely manner. In the first year we have successfully opened 16 radiotherapy centres and 13 referring centres with a further 6 radiotherapy centres expected to open shortly. The average time from SSI approval and opening is 6.5 months, the time taken for local R+D approval, QA approval, and to establish site agreements. A further 1 month average ‘lag’ time follows before a centre enters their first patient.

IMPORT LOW has involved a change of practice in the radiotherapy departments of some centres. Accurate localisation of the tumour bed for planning the partial breast radiotherapy fields initially caused some difficulties. The use of titanium ligaclips at during surgery has been shown by a recent audit conducted at Addenbrooke’s hospital to be essential for planning partial breast radiotherapy and also of great benefit to patients outside the trial receiving whole breast radiotherapy. This practice was initially undertaken by only 3 of our centres and has now been implemented in all participating centres. The use of clips will shortly be endorsed by BASO as best practice.

We describe our strategies for enhancing recruitment and overcoming the technical difficulties of delivery to improve accrual. 

IMPORT LOW tests the benefits of partial breast radiotherapy in patients at lower than average risk of local tumour recurrence following breast conserving surgery.

Building on the successful network developed by the START and FAST trials we aim to open 35 UK radiotherapy centres and their referring centres, to recruit 1934 patients in a timely manner. In the first year we have successfully opened 16 radiotherapy centres and 13 referring centres with a further 6 radiotherapy centres expected to open shortly. The average time from SSI approval and opening is 6.5 months, the time taken for local R+D approval, QA approval, and to establish site agreements. A further 1 month average ‘lag’ time follows before a centre enters their first patient.

IMPORT LOW has involved a change of practice in the radiotherapy departments of some centres. Accurate localisation of the tumour bed for planning the partial breast radiotherapy fields initially caused some difficulties. The use of titanium ligaclips at during surgery has been shown by a recent audit conducted at Addenbrooke’s hospital to be essential for planning partial breast radiotherapy and also of great benefit to patients outside the trial receiving whole breast radiotherapy. This practice was initially undertaken by only 3 of our centres and has now been implemented in all participating centres. The use of clips will shortly be endorsed by BASO as best practice.

We describe our strategies for enhancing recruitment and overcoming the technical difficulties of delivery to improve accrual.