Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial
- Conditions
- Locally Advanced Rectal CancerLocally Recurrent Rectal Cancer
- Interventions
- Radiation: Intraoperative Electron Radiotherapy (IOERT)Procedure: Extended Margin Surgery
- Registration Number
- NCT05877352
- 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).
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 31
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Dose IOERT Extended Margin Surgery Extended margin surgery and IOERT at higher dose (15 Gy) No IOERT Extended Margin Surgery Extended margin surgery Low Dose IOERT Extended Margin Surgery Extended margin surgery and IOERT at standard dose (10 Gy) High Dose IOERT Intraoperative Electron Radiotherapy (IOERT) Extended margin surgery and IOERT at higher dose (15 Gy) Low Dose IOERT Intraoperative Electron Radiotherapy (IOERT) Extended margin surgery and IOERT at standard dose (10 Gy)
- Primary Outcome Measures
Name Time Method Patients meeting eligibility criteria 2 years Number and percentage of patients meeting eligibility criteria and number of patients referred to a sMDT over the trial period
Successful delivery of IOERT 2 years Number and percentage of patients for which IOERT was successfully delivered as planned as part of the trial
Questionnaire analysis 2 years Percentage of patients whose questionnaires can be analysed
Availability of potential primary outcome data 2 years Percentage of patients for whom we can collect information on potential primary outcomes
Blind maintained for patients and clinicians 2 years Number and percentage of patients and clinicians for which blinding was maintained for IOERT delivery
Patients accepting randomisation 2 years Number and percentage of patients accepting randomisation
- Secondary Outcome Measures
Name Time Method Morbidity Up to 30 days post randomisation Clavien Dindo classification
IOERT Field Recurrence 12 months post randomisation 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.
Overall survival 12 months post randomisation Overall survival
Treatment related toxicity 12 months post randomisation Treatment related toxicity graded by CTCAE v5
LRRC QoL At 3 and 12 months post randomisation Quality of life scored from LRRC QoL
Overall local recurrence 12 months post randomisation Overall local recurrence (OLR) is defined as including both IOERT-field and non-IOERT field loco-regional recurrences.
Resource use and cost At 3 and 12 months post randomisation 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.
SF-36 At 3 and 12 months post randomisation Quality of life scored from SF-36
Mortality 30 days post randomisation Mortality
Time to local or systemic recurrence Time from randomisation to local or systemic recurrence or 3 years post the start of recruitment, whichever comes first Time to local or systemic recurrence
EQ-5D-5L At 3 and 12 months post randomisation Quality of life scored from EQ-5D-5L
QLQ-C30 At 3 and 12 months post randomisation Quality of life scored from QLQ-C30
R1 Rate At randomisation R1 Rate
Trial Locations
- Locations (1)
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, Hampshire, United Kingdom