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

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ClinicalTrials.gov Identifier: NCT03899636
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date April 10, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03899636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stage III Pancreatic Cancer
Intervention  ICMJE
  • Drug: Modified FOLFIRINOX Regimen
    Chemotherapy regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin
  • Device: NanoKnife System
    IRE using NanoKnife System
Study Arms  ICMJE
  • Experimental: IRE
    Interventions:
    • Drug: Modified FOLFIRINOX Regimen
    • Device: NanoKnife System
  • Active Comparator: Control
    Intervention: Drug: Modified FOLFIRINOX Regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
528
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alicia Conway 5086587990 ext 7939 aconway@angiodynamics.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03899636
Other Study ID Numbers  ICMJE 28-001-ONC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angiodynamics, Inc.
Study Sponsor  ICMJE Angiodynamics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Angiodynamics, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP