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Locally Advanced Rectal CancerELECTRANCT05877352

Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

A study testing Intraoperative Electron Radiotherapy (IOERT) and Extended Margin Surgery in people with Locally Advanced Rectal Cancer and Locally Recurrent Rectal Cancer, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Intraoperative Electron Radiotherapy (IOERT) and Extended Margin Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited Kingdom
Study dates
18 May 2022to 25 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

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).

Read the detailed description

Rectal cancer is a cancer that occurs in the pelvis from the rectum. Locally advanced rectal cancer outgrows the rectum and attaches to other body parts in the pelvis and locally recurrent rectal cancer is a rectal cancer that comes back after surgery, and usually attaches to many different pelvic structures. They are both difficult to manage. The standard of care treatment involves chemotherapy and radiotherapy, followed by what is known as an extended margin operation to remove all cancer affected organs and not leave any cancer cells behind. If cancer cells reach the edge of the removed tissue, there is a high chance of leaving cancer cells behind. This is a key predictor of negative outcome in patients. Intraoperative electron beam radiotherapy (IOERT) was developed to help improve patient outcomes. Once the cancer has been removed, the surgeon and a cancer radiotherapy specialist examine the patient's scans, the cancer specimen and the area the cancer was in, and if there is concern about small numbers of cancer cells being left behind they treat the area with radiotherapy to destroy these cells. Patients that are due to receive treatment for these subsets of rectal cancer will be approached to take part. If eligible on the day of surgery the patient will be randomised to one of three arms: Arm A - standard of care (No IOERT), Arm B - extended margin surgery plus IOERT (10 Gy), or Arm C - extended margin surgery plus higher dose IOERT (15 Gy). The surgeon, cancer specialist team and patient will be blinded to study treatment. Patients will be followed up at 30 days, 3 months and for a minimum of 12 months post surgery as part of the trial and they will be followed up for 5 years as part of standard care.

Being tested
Intraoperative Electron Radiotherapy (IOERT), Extended Margin Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Extended Margin SurgeryProcedure or surgery

    Surgery intended to remove both a tumour and any metastases

Study groups in NCT05877352
Study groupRoleWhat they receive
No IOERTActive comparatorExtended margin surgery
Receives: Procedure: Extended Margin Surgery
Low Dose IOERTExperimentalExtended margin surgery and IOERT at standard dose (10 Gy)
Receives: Radiation: Intraoperative Electron Radiotherapy (IOERT); Procedure: Extended Margin Surgery
High Dose IOERTExperimentalExtended margin surgery and IOERT at higher dose (15 Gy)
Receives: Radiation: Intraoperative Electron Radiotherapy (IOERT); Procedure: Extended Margin Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients meeting eligibility criteria

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

    Measured: 2 years

  2. Patients accepting randomisation

    Number and percentage of patients accepting randomisation

    Measured: 2 years

  3. Successful delivery of IOERT

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

    Measured: 2 years

  4. Blind maintained for patients and clinicians

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

    Measured: 2 years

  5. Questionnaire analysis

    Percentage of patients whose questionnaires can be analysed

    Measured: 2 years

  6. Availability of potential primary outcome data

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

    Measured: 2 years

Secondary outcomes (13)

  1. Morbidity

    Clavien Dindo classification

    Measured: Up to 30 days post randomisation

  2. Mortality

    Mortality

    Measured: 30 days post randomisation

  3. IOERT Field Recurrence

    IOERT Field Recurrence is defined as the area directly within the IOERT field as marked by ligaclips or identified by the surgical oncologist for future radiological surveillance.

    Measured: 12 months post randomisation

  4. Overall local recurrence

    Overall local recurrence (OLR) is defined as including both IOERT-field and non-IOERT field loco-regional recurrences.

    Measured: 12 months post randomisation

  5. Overall survival

    Overall survival

    Measured: 12 months post randomisation

  6. Treatment related toxicity

    Treatment related toxicity graded by CTCAE v5

    Measured: 12 months post randomisation

  7. Time to local or systemic recurrence

    Time to local or systemic recurrence

    Measured: Time from randomisation to local or systemic recurrence or 3 years post the start of recruitment, whichever comes first

  8. R1 Rate

    R1 Rate

    Measured: At randomisation

  9. EQ-5D-5L

    Quality of life scored from EQ-5D-5L

    Measured: At 3 and 12 months post randomisation

  10. LRRC QoL

    Quality of life scored from LRRC QoL

    Measured: At 3 and 12 months post randomisation

  11. QLQ-C30

    Quality of life scored from QLQ-C30

    Measured: At 3 and 12 months post randomisation

  12. SF-36

    Quality of life scored from SF-36

    Measured: At 3 and 12 months post randomisation

  13. Resource use and cost

    Cost will be estimated for the NHS. An NHS and social care perspective will be used, including intervention costs, outpatient visits and investigations, A\&E attendances, hospital admissions, number and dose of each radiotherapy treatment. Itemised resource usage date will be priced using appropriate national sources: Personal Social Services Research Unit (PSSRU), NHS Reference costs and BNF (British National Formulary) for the UK.

    Measured: At 3 and 12 months post randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study start18 May 2022
  3. Primary completion25 Apr 2024
  4. Study completion25 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05877352
Sponsor's protocol ID
RHMCAN1600
Other IDs
ISRCTN48105173
Acronym
ELECTRA
Status last verified
May 2025
First submitted
29 Mar 2023
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intraoperative Electron Radiotherapy (IOERT) and Extended Margin Surgery in people with Locally Advanced Rectal Cancer and Locally Recurrent Rectal Cancer, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients meeting eligibility criteria (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05877352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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