Intraoperative radiotherapy for pelvic cancer
Research type
Research Study
Full title
Feasibility study for the use of intraoperative single dose radiotherapy for locally advanced and recurrent pelvic cancer
IRAS ID
220972
Contact name
Jamie Murphy
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The aim of this feasibility study is to establish the short term safety of single dose IntraOperative RadioTherapy(IORT) for patients with advanced pelvic cancer. IORT allows radiation to be delivered directly to the area at high risk of local tumour recurrence. IORT can deliver a large dose of radiotherapy because radio-sensitive pelvic organs that normally limit the maximum radiation dose are temporarily displaced from the radiotherapy field by the surgeon.
The rationale for this study is limited published data suggest improved local control and disease free survival using IORT for locally advanced and recurrent pelvic cancer. A meta-analysis assessing colorectal cancer patients showed no increase in significant complications with IORT. Similarly, this therapy has been promising for other tumours, such as: endometrial, cervical, renal, bladder and prostate. At present, IORT is not approved by the National Institute for Clinical Excellence for tumours, however is recommended for breast cancer. Furthermore, while the Xoft Axxent electronic brachyterapy system for delivery of IORT during this study has been FDA approved and received a CE Mark, it has not yet been used for pelvic IORT. Therefore, this study is being undertaken to confirm the safety profile of this therapy.
All patients considered for inclusion will be discussed at the appropriate cancer Multidisciplinary Team (MDT) meeting. Potential candidates will be approached by a treating clinician to provide the study patient information sheet and answer any questions. Following this the patient will be invited to participate in this study. If they decide to participate, a clinician will obtain written consent prior to enrolment in the study. Written consent for the delivery of IORT will be taken by the treating Consultant Oncologist. IORT will be delivered at the time of surgery and study participants will be followed up in keeping with all local or national clinical guidelines.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
17/LO/1036
Date of REC Opinion
10 Aug 2017
REC opinion
Further Information Favourable Opinion