TARGIT R: Initiation and maintenance of a registry database of patients treated with targeted intraoperative radiation therapy using Intrabeam (TARGIT) following breast conserving surgery for early breast cancer.
Breast cancer is the most common cancer in the UK. With the introduction of the breast screening program a large number of patients in early stages of diagnosis are seen. However, all of these patients are currently subjected to standard radiotherapy which is given several months after surgery and would normally consist of a 3-5 week course of daily radiotherapy to the whole breast, as well as a shorter 5-8 day course to the tumour bed.
Results from the TARGIT A randomised controlled trial in low risk women over the age of 45 years, showed that giving a single dose of radiation with the TARGIT technique at the time of operation gave similar results as the usual several weeks' course of radiotherapy.
Studies show that breast cancer patients due to a large number of reason are given or choose to have their breast removed completely (mastectomy) because they cannot afford to travel great distance to their nearest radiotherapy centre, or cannot afford the time away from their responsibilities for the 15-25 days required for daily treatment. In some cases, blindness, previous external beam radiotherapy, claustrophobia, or age preclude these patients from having external beam radiotherapy. In such cases, some we would like to collect all this data to enhance future decisions regarding best treatment practices for these subgroups of patients.
The TARGIT R (registry) study has been set up to gather further information on the technique in a much more diverse population with early breast cancer. The primary objective is to monitor safety and toxicity on patients treated outside of a randomised controlled trial. In addition, careful monitoring of the data will enable us to see early indications of subgroups of patients, or clinical teams, which show higher than expected rates of local recurrence (effectiveness) Cost effectiveness data and long term cardio pulmonary events will also be collected as secondary endpoints.
Sponsored by: University College London (UCL)
ISRCTN Number: ISRCTN91179875
Clintrial.gov Number: NCT02947425