Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

NCT05877352 | Active Not Recruiting DMC

• 2 other identifiers: RHMCAN1600ISRCTN48105173
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Patients meeting eligibility criteria

  Number and percentage of patients meeting eligibility criteria and number of patients referred to a sMDT over the trial period

  2 years

• Patients accepting randomisation

  Number and percentage of patients accepting randomisation

  2 years

• Successful delivery of IOERT

  Number and percentage of patients for which IOERT was successfully delivered as planned as part of the trial

  2 years

• Blind maintained for patients and clinicians

  Number and percentage of patients and clinicians for which blinding was maintained for IOERT delivery

  2 years

• Questionnaire analysis

  Percentage of patients whose questionnaires can be analysed

  2 years

• Availability of potential primary outcome data

  Percentage of patients for whom we can collect information on potential primary outcomes

  2 years

Secondary Outcomes (13)

• Morbidity

  Up to 30 days post randomisation

• Mortality

  30 days post randomisation

• IOERT Field Recurrence

  12 months post randomisation

• Overall local recurrence

  12 months post randomisation

• Overall survival

  12 months post randomisation

Study Arms (3)

No IOERT

ACTIVE COMPARATOR

Extended margin surgery

Procedure: Extended Margin Surgery

Low Dose IOERT

EXPERIMENTAL

Extended margin surgery and IOERT at standard dose (10 Gy)

Radiation: Intraoperative Electron Radiotherapy (IOERT); Procedure: Extended Margin Surgery

High Dose IOERT

EXPERIMENTAL

Extended margin surgery and IOERT at higher dose (15 Gy)

Radiation: Intraoperative Electron Radiotherapy (IOERT); Procedure: Extended Margin Surgery

Interventions

Intraoperative Electron Radiotherapy (IOERT) RADIATION

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.

High Dose IOERT; Low Dose IOERT

Extended Margin Surgery PROCEDURE

Surgery intended to remove both a tumour and any metastases

High Dose IOERT; Low Dose IOERT; No IOERT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• IntraOp Medical Corporation: collaborator
• PLANETS Cancer Charity: collaborator
• Cancer Research UK: collaborator

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Study Officials

• Alex Mirnezami, Prof

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blinded trial, which means both the participant and clinicians will not know the treatment allocation. The surgeon, oncologist and patient will remain blinded throughout the study, while the radiotherapy delivery team will know the outcome of the randomisation. Patient allocation will be provided to the unblinded radiotherapy staff via an Interactive Web Response System (IWRS). The randomisation code will be retained by the system. Deaths and serious adverse events (SAE) will be reviewed in a blinded manner. Unblinding will be required in the event that any participants further treatment may benefit from further radiotherapy, and if potential IOERT treatment and its dose may impact this.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 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 (no IOERT) in a 1:1:1 ratio in patients with LARC or LRRC.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 26, 2023
• Study Start: May 18, 2022
• Primary Completion: April 25, 2024
• Study Completion: July 25, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)