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NCT03899636 · ClinicalTrials.gov registry record · Phase 3
A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer
A Phase 3 study of Stage III Pancreatic Cancer, sponsored by Angiodynamics.
- Active
- Registry status
- Phase 3
- Development phase
- 528
- Enrollment target
- 6
- Study locations
NCT03899636 is a Phase 3 study of Stage III Pancreatic Cancer that is active but no longer recruiting, run by Angiodynamics. The registered enrollment target is 528 participants, above the 126-participant average among 13 other Stage III Pancreatic Cancer trials with a reported enrollment target (319% higher). The trial reports 6 study locations across 5 states.
The verdict
NCT03899636, a Phase 3 study of Stage III Pancreatic Cancer, is active but no longer recruiting, sponsored by Angiodynamics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 528 participants
- Enrollment target
- 6
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 528 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 126-participant average among 13 other Stage III Pancreatic Cancer trials with a reported enrollment target (319% higher). The listed sponsor is Angiodynamics, which has 12 total studies on file at ClinicalTrials.gov.
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.
NCT03899636 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Florida, Illinois, Kentucky.
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.
What interventions are being tested in trial NCT03899636?
The interventions under investigation include: Modified FOLFIRINOX Regimen (DRUG), NanoKnife System (DEVICE).
Who is sponsoring clinical trial NCT03899636?
This trial is sponsored by Angiodynamics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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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Related
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