NCT05877352Active, not recruiting
Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 29 Mar 2023
- Start date
- 18 May 2022
- Primary completion date
- 25 Apr 2024
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Diseases
- Childhood cancers
- NCT number
- NCT05877352
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 18 May 2022 to the primary completion date, 25 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- sMDT determined excess prior radiotherapy within IOERT target zone
Other illness
- Unresectable disease/likelihood of R2 resection
Other
- Women who are pregnant or breastfeeding
- Participation within an interventional clinical trial within 3 months of the point of registration within ELECTRA
Who the study is looking for
- 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
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.