A feasibility study of electron radiotherapy delivered during a surgical operation for rectal cancer
- Conditions
- Colorectal CancerCancer
- Registration Number
- ISRCTN48105173
- Lead Sponsor
- niversity Hospital Southampton NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 42
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method