A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer (DIRECT)

November 23, 2022 updated by: Angiodynamics, Inc.

A Randomized, Multicenter, Controlled, Unblinded Study to Assess the Safety and Efficacy of the NanoKnife® System for the Ablation of Unresectable Stage 3 Pancreatic Adenocarcinoma

Subjects will be offered the opportunity to participate in a randomized, controlled, 2-arm, unblinded multicenter trial (RCT). There will be 2 study arms: the control arm receiving chemotherapy with the modified FOLFIRINOX regimen alone; and the irreversible electroporation (IRE) arm, receiving chemotherapy with the modified FOLFIRINOX regimen followed by IRE with the NanoKnife System using either an open or a percutaneous approach. All subjects will be treated with the modified FOLFIRINOX regimen for at least 3 months; randomization to either control or IRE arm will take place at the time of completion of the 3 month modified FOLFIRINOX chemotherapy regimen. Randomization will be conducted centrally. Subjects will be randomized in a 1:1 ratio and must be found to have no evidence of disease progression after completion of the 3 month modified FOLFIRINOX chemotherapy regimen in order to participate in the RCT. All radiologic assessments will be performed as consistent with the imaging protocol. All post induction and post IRE treatments are left to the discretion of the treating physician. The minimum period of follow-up will be for 24 months or until death.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

528

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
        • Contact:
          • Govindarajan Narayanan, MD
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida/Tampa
        • Contact:
          • Thanh Tran
        • Principal Investigator:
          • Vic Velanovich, MD
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Recruiting
        • Northwest Community Healthcare
        • Contact:
          • Henry Mantakul
        • Principal Investigator:
          • Malcolm Bilimoria, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Healthcare
        • Contact:
          • Mary Healey
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Recruiting
        • St. Luke's Cancer Center
        • Principal Investigator:
          • Darius Desai, MD
        • Contact:
          • Janine Schippang
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • University of Texas-Southwestern
        • Principal Investigator:
          • Patricio Polanco, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.
  2. Subject is 18 years of age and older.
  3. Subject has a diagnosis of unresectable Stage 3 pancreatic adenocarcinoma cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria.
  4. Subject 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 receiving three months of treatment with the modified FOLFIRINOX regimen.
  6. Subject has received 3 months of treatment with the modified FOLFIRINOX regimen.
  7. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  8. Subject has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.

Exclusion Criteria:

  1. Subjects who are or may be pregnant as determined by a positive pregnancy test or breastfeeding 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.
  2. Subjects who are unable to tolerate general anesthetic with full skeletal muscle blockade.
  3. Subjects who are actively bleeding, anticoagulated, coagulopathy, or have any of the following hematology results: hemoglobin less than 10 g/dL without the support of growth factors or transfusions absolute neutrophil count less than 1500 cells/mL; or platelet count less than 100,000.
  4. Subjects 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.
  5. Subjects with history of epilepsy or other neurological disease.
  6. Subjects with renal, cardiac, liver, or hematological abnormalities of concern to the investigator.
  7. Subjects with Stage 3, 4, or 5 chronic kidney disease.
  8. Subjects receiving IRE for margin accentuation.
  9. Subjects who at 3 months after FOLFIRINOX treatment have evidence of disease progression.
  10. Participation in another interventional trial for pancreatic cancer.
  11. Subjects who did not meet study defined criteria for adequacy of induction treatment at the end of the 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Drug: Modified FOLFIRINOX Regimen
Chemotherapy regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin
Experimental: IRE
Drug: Modified FOLFIRINOX Regimen
Chemotherapy regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin
Device: NanoKnife System
IRE using NanoKnife System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Time (in months) from randomization to the date of death for any reason, assessed through at least 24 months.
Time (in months) from randomization to the date of death for any reason
Time (in months) from randomization to the date of death for any reason, assessed through at least 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiodynamics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28-001-ONC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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