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A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer
NCT03899636 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Modified FOLFIRINOX Regimen
- DEVICE NanoKnife System
Study Locations (6)
Florida
- Miami Cancer Institute — Miami
- University of South Florida/Tampa — Tampa
Illinois
- Northwest Community Healthcare — Arlington Heights
Kentucky
- Norton Healthcare — Louisville
Pennsylvania
- St. Luke's Cancer Center — Easton
Texas
- University of Texas-Southwestern — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 528 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2025-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03899636
The ClinicalTrials.gov registry entry for NCT03899636 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 528 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Angiodynamics, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Stage III Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions — of which Modified FOLFIRINOX Regimen is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03899636 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Florida, Illinois, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03899636 about?
NCT03899636 is a clinical study titled "A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer". 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 chem...
What is the current status of trial NCT03899636?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 528 participants. The study started on 2021-02-23. Estimated completion is 2025-04.
What conditions does trial NCT03899636 study?
This clinical trial studies the following conditions: Stage III Pancreatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03899636?
The interventions under investigation include: Modified FOLFIRINOX Regimen (DRUG), NanoKnife System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03899636?
This trial is sponsored by Angiodynamics, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03899636 being conducted?
This trial has 6 study locations across Florida, Illinois, Kentucky, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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