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Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

NCT05877352 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-05-14

No results posted yet for this study

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).

Conditions

  • Locally Advanced Rectal Cancer
  • Locally Recurrent Rectal Cancer

Interventions

RADIATION

Intraoperative Electron Radiotherapy (IOERT)

IOERT can be defined as the direct application of high-energy electron beam irradiation to a tumour bed during an operative procedure. This approach permits precise delivery of a single large fraction of radiation directly and specifically to high recurrence risk anatomical target areas, which the treating clinicians (surgeon and attending clinical oncologist) predict will be a close or involved margin, while simultaneously displacing and shielding dose-limiting radiosensitive structures such as the small bowel or ureter or any anastomoses, if not involved by tumour.

PROCEDURE

Extended Margin Surgery

Surgery intended to remove both a tumour and any metastases

Sponsors & Collaborators

  • IntraOp Medical Corporation

    collaborator UNKNOWN

  • PLANETS Cancer Charity

    collaborator UNKNOWN

  • Cancer Research UK

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Alex Mirnezami, Prof · University Hospital Southampton NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2024-04-25
Completion
2027-04-25

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05877352 on ClinicalTrials.gov