Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

N/AActive Not RecruitingNCT05877352

University Hospital Southampton NHS Foundation Trust31 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Locally Advanced Rectal Cancer Locally Recurrent Rectal Cancer

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.

Extended Margin SurgeryPROCEDURE

Surgery intended to remove both a tumour and any metastases

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

Outcomes

Primary Outcomes

Patients meeting eligibility criteria

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

Time frame: 2 years

Patients accepting randomisation

Number and percentage of patients accepting randomisation

Time frame: 2 years

Successful delivery of IOERT

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

Time frame: 2 years

Blind maintained for patients and clinicians

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

Time frame: 2 years

Questionnaire analysis

Percentage of patients whose questionnaires can be analysed

Time frame: 2 years

Availability of potential primary outcome data

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

Time frame: 2 years

Secondary Outcomes

Morbidity

Clavien Dindo classification

Time frame: Up to 30 days post randomisation

Mortality

Time frame: 30 days post randomisation

Data from ClinicalTrials.gov

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