Investigation of the safety and effectiveness of irreversible electroporation (IRE) using the NanoKnife® System in patients with unresectable stage 3 pancreatic cancer who have received 3 months of chemotherapy.
- Conditions
- Pancreatic CancerCancer - Pancreatic
- Registration Number
- ACTRN12621000955819
- Lead Sponsor
- Walter & Eliza Hall Institute of Medical Research (WEHI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1 Patient has a diagnosis of unresectable Stage 3 pancreatic ductal adenocarcinoma cancer cytologically or pathologically confirmed as per American Joint Committee on Cancer (AJCC) staging criteria.
2 Patient is newly diagnosed and has only received a single line of therapy for at least 3 months prior to enrolment. They must have received either modified FOLFIRINOX or gemcitabine-based chemotherapy.
3 Patient has a tumour evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery.
4 Maximum axial tumour dimension of less than or equal to 3.5cm, after receiving at least three months of treatment with a modified FOLFIRINOX or gemcitabine-based regimen.
5 Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6 Patient has an American Society of Anaesthesiologists (ASA) classification of physical health status of 1 or 2.
1 Patients who at 3 months after induction chemotherapy have evidence of disease progression.
2 Patients who have undergone prior radiation therapy or surgical resection for treatment of pancreatic cancer.
3 Patients who have received IRE for margin accentuation.
4 Patients who are unable to tolerate general anaesthetic with full skeletal muscle blockade.
5 History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in-situ.
6 Patients who are actively bleeding, anticoagulated, coagulopathy, or have any of the following haematology results:
a.Haemoglobin <100 g/L without the support of growth factors or transfusion
b.Absolute neutrophil count <1.5 x 109/L
c.Platelet count <100 x 109/L
7 Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE.
8 Patients with history of epilepsy or other neurological disease.
9 Patients with inadequate organ function:
a.Patients with Stage 3 (GFR 30 to 44ml/min), 4 (15 to 29ml/min), or 5 (<15ml/min) chronic kidney disease.
b.Aspartate aminotransferase/alanine aminotransferase >2.5 x upper limit of normal.
c.Clinically significant cardiovascular disease i.e. active or <12 months since e.g. cerebrovascular accident, myocardial infraction, unstable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmias requiring medications, uncontrolled hypertension.
10 Patients who are pregnant or breastfeeding. Women of childbearing potential (WOCBP) must undergo pregnancy testing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method