ELECTRA
Research type
Research Study
Full title
A double-blinded feasibility study of intraoperative electron radiotherapy in patients with locally advanced or locally recurrent rectal cancer
IRAS ID
292873
Contact name
Alexander Mirnezami
Contact email
Sponsor organisation
University Hospital Southampton
ISRCTN Number
ISRCTN48105173
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Rectal cancer is a cancer that occurs in the pelvis from the rectum. Locally advanced rectal cancer outgrows the rectum and attaches to other body parts in the pelvis and locally recurrent rectal cancer is a rectal cancer that comes back after surgery, and usually attaches to many different pelvic structures. They are both difficult to manage. The standard of care treatment involves chemotherapy and radiotherapy, followed by what is known as an extended margin operation to remove all cancer affected organs and not leave any cancer cells behind. If cancer cells reach the edge of the removed tissue, there is a high chance of leaving cancer cells behind. This is a key predicter of negative outcome in patients. Intraoperative electron beam radiotherapy (IOERT) was developed to help improve patient outcomes. Once the cancer has been removed, the surgeon and a cancer radiotherapy specialist examine the patient’s scans, the cancer specimen and the area the cancer was in, and if there is concern about small numbers of cancer cells being left behind they treat the area with radiotherapy to destroy these cells. Patients that are due to receive treatment for these subsets of rectal cancer will be approached to take part. If eligible on the day of surgery the patient will be randomised to one of three arms: Arm A – standard of care (No IOERT), Arm B – extended margin surgery plus IOERT (10 Gy), or Arm C – extended margin surgery plus higher dose IOERT (15 Gy). The surgeon, cancer specialist team and patient will be blinded to study treatment. Patients will be followed up at 30 days, 3 months and for a minimum of 12 months post surgery as part of the trial and they will be followed up for 5 years as part of standard care.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
22/WM/0048
Date of REC Opinion
31 Mar 2022
REC opinion
Further Information Favourable Opinion