Trial ID: ISRCTN14986389
Other - Phase Unknown - No longer available
Background and study aims Surgery (pancreatic resection) is the only treatment with the potential to cure pancreatic cancer. Only 10 to 20 out of every 100 people are eligible for surgery. One of the major reasons is that the cancer has spread into the surrounding structures, which is known as locally advanced pancreatic cancer (LAPC). Currently, the recommended treatment for LAPC is chemotherapy (drugs which destroy cancer). Those in whom the chemotherapy prevents the growth or spread of cancer have a chance of improved survival. Irreversible electroporation (IRE) is a new method of treating cancer. IRE treatment destroys cancer cells by electricity. Under general anaesthetic, IRE probes, which are similar to needles, are inserted into the pancreas and an electrical charge is passed through the cancer. Early studies in pancreas cancer suggest that IRE treatment may increase how long people with LAPC live. However, there has been no trial to provide evidence of how effective IRE treatment is in people with LAPC that is unsuitable for surgery. This study aims to find out how feasible it would be to carry out a trial of IRE treatment following initial chemotherapy for LAPC. The study will also investigate the safety, practicality, and technical success of IRE treatment, how acceptable IRE treatment is to patients and their doctors, how many participants are recruited and withdraw from the study, participant survival, and participant quality of life. Who can participate? Adults with locally advanced pancreatic cancer who are not suitable for surgical resection What does the study involve? Following first-line chemotherapy with Folfirinox, participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). One group will receive the IRE procedure followed by standard-of-care chemotherapy, and the other group will receive standard-of-care chemotherapy alone. Patients will be followed up every 3 months for 12 months where they will undergo blood tests and CT scans. What are the possible benefits and risks of participating? The aim of IRE for LAPC is to provide an improvement in life expectancy and a better quality of life. There is data to suggest this may be effective but it has not yet been proven. Risks associated with IRE that may rarely occur in a small number of participants include: pain at the treatment site; acute pancreatitis; local vascular occlusion from thrombosis; leakage of fluid from the pancreas, bile duct or duodenum at the insertion point of the IRE probes; and cardiac arrhythmias. Where is the study run from? Liverpool Clinical Trials Centre (UK) When is the study starting and how long is it expected to run for? From October 2020 to February 2025 Who is funding the study? National Institute for Health Research (NIHR) Research for Patient Benefit programme (UK) Who is the main contact? Dr Kellie Platt, lappie@liverpool.ac.uk
Royal Free London NHS Foundation Trust
Source: https://www.isrctn.com/