Clinical trial NCT03899649: A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer
Official title: Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stage III Pancreatic Cancer
Keywords: Pancreas Cancer
Pancreatic Adenocarcinoma
Pancreatic Ductal Adenocarcinoma
Advanced Pancreatic Cancer
Carcinoma, Pancreatic Ductal
Locally Advanced Pancreatic Cancer
Cancer of Pancreas
Pancreatic Tumor
Pancreatic Carcinoma
Unresectable Pancreatic Cancer
LAPC
Lead sponsor: Angiodynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-02
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cytologically or pathologically confirmed Stage 3 PC who are treated, in real-world treatment settings and as part of routine clinical practice, with the NanoKnife System (at least 266 patients) for the ablation of their tumor in addition to SOC (IRE cohort), or with SOC only (at least 266 patients) (SOC cohort). Patients will be enrolled after completing the initial 3-month treatment per SOC for Stage 3 PC.

Brief summary: 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 \[SOC cohort\].


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores Cancer Center, UC San Diego Health
state: California
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Marietta
country: United States
facility: Wellstar Medical Group
state: Georgia
city: Arlington Heights
country: United States
facility: Northwest Community Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Healthcare
state: Iowa
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic, Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: Presbyterian Hospital, Columbia
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Easton
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas-Southwestern
state: Texas
Study officials:
References:
citation: Narayanan G, Bilimoria MM, Hosein PJ, Su Z, Mortimer KM, Martin RCG 2nd. Multicenter randomized controlled trial and registry study to assess the safety and efficacy of the NanoKnife(R) system for the ablation of stage 3 pancreatic adenocarcinoma: overview of study protocols. BMC Cancer. 2021 Jul 7;21(1):785. doi: 10.1186/s12885-021-08474-4.