ELECTRA – intraoperativE eLECtron radioTherapy in Rectal cAncer

Background Colorectal cancer is the third most common cancer in the UK and represents the second highest cause of cancer mortality and cancer-related health care expenditure.

The rectum is the commonest site affected by adenocarcinoma of the colorectum, with an incidence of over 16,093 patients in the UK each year (2014 figures; Cancer Research UK).

Locally advanced rectal cancer (LARC) affects approximately 10-15% of patients and local recurrence of rectal cancer (LRRC) can affect up to a further 12% amounting to between 3540-4344 patients affected in the UK each year. Local recurrence has severe symptoms and impairs Quality of Life (QoL) significantly.

As such LARC and LRRC represent a major focus of the UK ACPGBI IMPACT initiative (Improving Management for Patients with Advanced Colorectal Tumours).

Surgery remains the best option for cure in patients with rectal cancer, provided that the tumour can be completely removed but recurrence is still an issue.

Intraoperative electron beam radiotherapy (IOERT) has emerged as an additional and potentially valuable modality in the management of these most challenging cases, aiming to improve local control but to date there have been no randomised studies to assess the effectiveness of it in CRC.

Aims This is a feasibility study to evaluate the role of adding Intra Operative Electron beam Radiotherapy (IOERT) to surgery in the treatment of patients with locally advanced or locally recurrent rectal cancer, in terms of acceptability of the treatment randomisation and blinding.

Methods 42 patients eligible to receive IOERT will be randomised into 1 of 3 arms; No IOERT, Low dose IOERT; High dose IOERT. Patients will be blinded to their treatment. Patients will be followed up for 12 months post treatment. How the results of this research will be used The results will inform a large randomised phase II trial.