Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial (ELECTRA)

University Hospital Southampton NHS Foundation Trust

Status: Active, not recruiting

Conditions: Locally Advanced Rectal Cancer; Locally Recurrent Rectal Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05877352

ISRCTN48105173 (Registry Identifier)

RHMCAN1600

Details and patient eligibility

About

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).

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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31 participants in 3 patient groups

No IOERT

Active Comparator group

Description:

Extended margin surgery

Treatment:

Procedure: Extended Margin Surgery

Low Dose IOERT

Experimental group

Description:

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

Treatment:

Procedure: Extended Margin Surgery

Radiation: Intraoperative Electron Radiotherapy (IOERT)

High Dose IOERT

Experimental group

Description:

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

Treatment:

Procedure: Extended Margin Surgery

Radiation: Intraoperative Electron Radiotherapy (IOERT)