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

Last updated: February 11, 2025
Sponsor: Angiodynamics, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Digestive System Neoplasms

Treatment

Modified FOLFIRINOX Regimen

NanoKnife System

Clinical Study ID

NCT03899636
28-001-ONC
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 cancercytologically 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 CancerNetwork (NCCN) guidelines, based on radiographic imaging or exploratory surgery.

  5. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm, after receivingthree 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

  9. Subject has an American Society of Anesthesiologists (ASA) classification ofphysical health status of 1 or 2.

Exclusion

Exclusion Criteria:

  1. Subjects who are or may be pregnant as determined by a positive pregnancy test orbreastfeeding or male or female patients of reproductive potential who are notwilling to employ highly effective birth control from screening to 6 months afterthe last dose of chemotherapy.

  2. Subjects who are unable to tolerate general anesthetic with full skeletal muscleblockade.

  3. Subjects who are actively bleeding, anticoagulated, coagulopathy, or have any of thefollowing hematology results: hemoglobin less than 10 g/dL without the support ofgrowth factors or transfusions absolute neutrophil count less than 1500 cells/mL; orplatelet 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 atthe time of IRE.

  5. Subjects with history of epilepsy or other neurological disease.

  6. Subjects with renal, cardiac, liver, or hematological abnormalities of concern tothe 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 diseaseprogression.

  10. Participation in another interventional trial for pancreatic cancer.

  11. Subjects who did not meet study defined criteria for adequacy of induction treatmentat the end of the 3 months.

Study Design

Total Participants: 528
Treatment Group(s): 2
Primary Treatment: Modified FOLFIRINOX Regimen
Phase: 3
Study Start date:
February 23, 2021
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Mayo Clinic, Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Miami Cancer Institute

    Miami, Florida 33176
    United States

    Site Not Available

  • Orlando Regional Healthcare System

    Orlando, Florida 32806
    United States

    Site Not Available

  • University of South Florida/Tampa

    Tampa, Florida 33606
    United States

    Site Not Available

  • Northwest Community Healthcare

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Norton Healthcare

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Mayo Clinic, Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • University of Mississippi

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Columbia University Irving Medical Center / NYP

    New York, New York 10032
    United States

    Site Not Available

  • St. Luke's Cancer Center

    Easton, Pennsylvania 18045
    United States

    Site Not Available

  • University of Texas-Southwestern

    Dallas, Texas 75231
    United States

    Site Not Available

  • Christus Trinity Mother Frances Hospital

    Tyler, Texas 75702
    United States

    Site Not Available

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