Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial (NCT05877352) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial
United Kingdom31 participantsStarted 2022-05-18
Plain-language summary
Single centre double-blinded three-arm randomised controlled trial of extended margin surgery + IOERT at standard dose (10 Gy) versus extended margin surgery + IOERT at higher dose (15 Gy) versus extended margin surgery alone in a 1:1:1 ratio in patients with Locally Advanced Rectal Cancer (LARC) or Locally Recurrent Rectal Cancer (LRRC).
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 16
* Non-metastatic/oligo-metastatic (up to 3 lesions from 2 sites predicted to be radically treatable) - locally advanced or locally recurrent disease involving the posterior or lateral components of the pelvis and predicted to be resectable but with close margins from imaging as determined by a specialist MDT (sMDT)
* Colorectal sMDT review with experience in pelvic exenteration, which has proposed IntrOperative Electron Radiotherapy (IOERT) as an option for treatment
* Patient suitable for IOERT as component of treatment in the view of the responsible Clinical Oncologist
* Performance status ≤1 as defined by the Eastern Cooperative Oncology Group (ECOG)
* Deemed medically fit for surgery
* Written informed consent
Exclusion Criteria:
* Unresectable disease/likelihood of R2 resection
* sMDT determined excess prior radiotherapy within IOERT target zone
* Women who are pregnant or breastfeeding
* Participation within an interventional clinical trial within 3 months of the point of registration within ELECTRA
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patients meeting eligibility criteria
Timeframe: 2 years
2
Patients accepting randomisation
Timeframe: 2 years
3
Successful delivery of IOERT
Timeframe: 2 years
4
Blind maintained for patients and clinicians
Timeframe: 2 years
5
Questionnaire analysis
Timeframe: 2 years
6
Availability of potential primary outcome data
Timeframe: 2 years
Trial details
NCT IDNCT05877352
SponsorUniversity Hospital Southampton NHS Foundation Trust