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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03899636
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Stage III Pancreatic Cancer Drug: Modified FOLFIRINOX Regimen Device: NanoKnife System Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IRE Drug: Modified FOLFIRINOX Regimen
Chemotherapy regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin

Device: NanoKnife System
IRE using NanoKnife System
Active Comparator: Control Drug: Modified FOLFIRINOX Regimen
Chemotherapy regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899636


Contacts
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Contact: Alicia Conway 5086587990 ext 7939 aconway@angiodynamics.com

Locations
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United States, Florida
University of Miami Health System Recruiting
Miami, Florida, United States, 33136
Contact: Vivianne Velez-Bravo         
Principal Investigator: Peter Hosein, MD         
Miami Cancer Institute Recruiting
Miami, Florida, United States, 33176
Contact: Govindarajan Narayanan, MD         
Orlando Regional Healthcare System Recruiting
Orlando, Florida, United States, 32806
Contact: Theresa DeLeon         
Principal Investigator: Debashish Bose, MD         
University of South Florida/Tampa Recruiting
Tampa, Florida, United States, 33606
Contact: Thanh Tran         
Principal Investigator: Vic Velanovich, MD         
United States, Kentucky
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40202
Contact: Mary Healey         
United States, Missouri
Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Mary Pecoraro         
Principal Investigator: Chet Hammill, MD         
United States, New York
Columbia University Irving Medical Center / NYP Recruiting
New York, New York, United States, 10032
Contact: Jacqueline Morin         
Principal Investigator: Michael Kluger, MD         
United States, Texas
University of Texas-Southwestern Recruiting
Dallas, Texas, United States, 75231
Contact: Misbah Shabbir         
Principal Investigator: Patricio Polanco, MD         
Christus Trinity Mother Frances Hospital Recruiting
Tyler, Texas, United States, 75702
Contact: Amanda Baker         
Principal Investigator: Steven Curley, MD         
Sponsors and Collaborators
Angiodynamics, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT03899636    
Other Study ID Numbers: 28-001-ONC
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Angiodynamics, Inc.:
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
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
 Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Folfirinox
Antineoplastic Agents