A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer (DIRECT)

AngioDynamics

Status: Active, not recruiting

Conditions: Stage III Pancreatic Cancer

Treatments: Device: NanoKnife System; Drug: SOC

Study type: Observational

Funder types: Industry

Identifiers

NCT03899649

2019-ONC-02

Details and patient eligibility

About

This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) [IRE cohort], and patients who were treated with SOC and did not receive IRE [SOC cohort].

Enrollment: 532 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provisions of signed and dated informed consent form
2. Patient is 18 years of age and older
3. Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
4. Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
5. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
6. Patient has received 3 months of SOC per each participating institution's guidelines
7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.
9. Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System
10. Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC

Exclusion criteria

1. Participation in an interventional trial for pancreatic cancer during the study data collection period
2. Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy
3. Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
4. 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

Trial design

532 participants in 2 patient groups

IRE Cohort

Description:

Patients who received SOC and received IRE

Treatment:

Drug: SOC

Device: NanoKnife System

SOC Cohort

Description:

Patients who received SOC and did not receive IRE

Treatment:

Drug: SOC