A double-blinded feasibility study of intraoperative electron radiotherapy in patients with locally advanced or locally recurrent rectal cancer

niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 42 人开始时间: 2022年5月13日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•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

发起方

niversity Hospital Southampton NHS Foundation Trust