Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Stage III Pancreatic Cancer, sponsored by Angiodynamics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time (in months) from randomization to the date of death for any reason
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 |
What the registry record for NCT03899636 still lists
NCT03899636 is an interventional study that assigns participants to a tested intervention. The registered 528 participants enrollment target is mid-sized for trials with a published cap, above the 126-participant average among 13 other Stage III Pancreatic Cancer trials with a reported enrollment target (319% higher).
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 lists 6 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Stage III Pancreatic Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03899636's enrollment target sits among peer trials
528 3rd of 13 higher than 11 of 13 other Stage III Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Gemcitabine With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
COMPLETED · Phase 3
-
Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors
RECRUITING · Phase 2
-
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
ACTIVE NOT RECRUITING · Phase 1
-
Malnutrition Screening and Dietary Intervention to Improve Nutrition Outcomes in Patients With Unresectable Pancreatic Cancer
ACTIVE NOT RECRUITING · NA
-
A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer
ACTIVE NOT RECRUITING
-
Trametinib and Hydroxychloroquine in Treating Patients With Pancreatic Cancer
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05373017 · 528 participants · NA
Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors
- NCT05634252 · 528 participants · Phase 3
Undergraduate Skin Cancer Prevention Trial
- NCT06383273 · 528 participants · Phase 3
A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
- NCT06470243 · 528 participants · Phase 3
Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI