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RecruitingLast updated: 12 February 2024

DIRECT/InspIRE Australia: This study is evaluating the effectiveness of a procedure called irreversible electroporation, which uses electrical pulses to destroy cancer cells, in people with stage III pancreatic cancer who have received 3 months of chemotherapyInvestigation of the safety and efficacy of irreversible electroporation (IRE) using the NanoKnife® System in patients with unresectable stage 3 pancreatic cancer who have received 3 months of chemotherapy

Clinical summary

Summary

This is an open-label, prospective, multi-centre registry-based study evaluating the use of Irreversible Electroporation (IRE) with the NanoKnife system in unresectable stage 3 pancreatic cancer. Irreversible electroporation (IRE) is a technique using non-thermal energy to create permanent nanopores in the cell membrane in order to disrupt cellular homeostasis. After delivering a sufficient number of high voltage pulses, the cells within the electrical field will be irreversibly damaged. Eligible participants must have received 3 months of FOLFIRINOX or gemcitabine-based chemotherapy prior to enrolment. All participants will undergo IRE with the NanoKnife System, and the IRE procedure should be undertaken 1-3 weeks from the completion of 3 months of chemotherapy. Only a surgeon qualified in the use of the NanoKnife System will perform the procedure, and the procedure takes around 2-3 hours.

Conditions

This trial is treating patients with unresectable, stage III pancreatic cancer

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Phase

Not applicable

Trial Acronym

DIRECT/InspIRE Australia

More information

Trial Identifiers

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Trial sponsor

AngioDynamics,Walter and Eliza Hall Institute

Scientific Title

Investigation of the safety and efficacy of irreversible electroporation (IRE) using the NanoKnife® System in patients with unresectable stage 3 pancreatic cancer who have received 3 months of chemotherapy

Eligibility

Inclusion

 

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

Exclusion

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.

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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