Colorectal Cancer Cancer
Conditions
Interventions
As part of standard of care, patients with locally advanced or locally recurrent rectal cancer will have an extended margin operation to remove all cancer affected organs.
Participants who meet the el
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Age >=16 years 2. Non-metastatic/oligo-metastatic (up to three lesions from 2 sites predicted to be radically treatable) – locally advanced or locally recurrent disease involving the posterior or lateral compartment of the pelvis and predicted to be resectable but with close margins from MRI as determined by a specialist MDT (sMDT) 3. Specialist colorectal MDT review with experience in pelvic exenteration, which 4. has proposed IOERT as an option for treatment 5. Patient suitable for IOERT as a component of treatment in view of the 6. responsible Clinical Oncologist 7. Performance status <=1 as defined by the Eastern Cooperative Group (ECOG) 8. Deemed medically fit for surgery 9. Written informed consent
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 11/08/2023: 1. Unresectable disease/likelihood of R2 resection 2. sMDT determined excess prior radiotherapy within IOERT target zone 3. Women who are pregnant or breastfeeding 4. Participation within an interventional trial within 3 months of the point of registration within ELECTRA Previous participant exclusion criteria: 1. Unresectable disease/likelihood of R2 resection 2. sMDT determined excess prior radiotherapy within IOERT target zone 3. Women who are pregnant or breastfeeding 4. Use of experimental drugs within other interventional clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility measured at the end of the trial using: 1. Number and percentage of patients meeting eligibility criteria and number of patients referred to a specialist MDT over the trial period; 2. Number and percentage of patients accepting randomisation; 3. Number and percentage of patients for which IOERT was successfully delivered as planned; 4. Number and percentage of patients and clinicians for which blinding was maintained for IOERT delivery; 5. Percentage of patients whose questionnaires can be analysed; 6. Percentage of patients whom we can collect information on potential primary outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Morbidity measured using Clavien Dindo at surgery and at 30 days post randomisation 2. Mortality at 30 days post randomisation 3. Oncological outcomes: IOERT field occurrence, overall recurrence, overall survival at minimum 12 months post randomisation 4. Treatment related toxicity graded by CTCAE at minimum 12 months post randomisation 5. Time to local or systemic recurrence 6. R1 rate at surgery 7. Quality of life measured using questionnaires (EQ-5D-5L, LRRC-QoL, SF-36, EORTC QLQ-C30) at pre-op, 3 months and 12 months post surgery 8. Resource use and cost at pre-op, 3 months and 12 months post surgery | — |
Countries
England, United Kingdom
Contacts
Public ContactDaniel Griffiths
Outcome results
None listed