NCT03899636Active, not recruitingPhase 3
A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer
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
Source: ClinicalTrials.gov · Last updated 12 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 528 (estimated)
- First submitted
- 29 Mar 2019
- Start date
- 23 Feb 2021
- Primary completion date
- Apr 2025
- Lead sponsor
- Angiodynamics, Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT03899636
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 528
- From 23 Feb 2021 to the primary completion date, Apr 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Subjects receiving IRE for margin accentuation.
Other illness
- 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.
- Subjects with history of epilepsy or other neurological disease.
- Subjects with renal, cardiac, liver, or hematological abnormalities of concern to the investigator.
- Subjects with Stage 3, 4, or 5 chronic kidney disease.
- Subjects who at 3 months after FOLFIRINOX treatment have evidence of disease progression.
- Participation in another interventional trial for pancreatic cancer.
Lab values
- 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.
Other
- Subjects who are unable to tolerate general anesthetic with full skeletal muscle blockade.
- Subjects who did not meet study defined criteria for adequacy of induction treatment at the end of the 3 months.
Who the study is looking for
- Provision of signed and dated informed consent form.
- Subject is 18 years of age and older.
- Subject has a diagnosis of unresectable Stage 3 pancreatic adenocarcinoma cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria.
- Subject has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery.
- Maximum axial and anterior to posterior tumor dimension of ≤3.5cm, after receiving three months of treatment with the modified FOLFIRINOX regimen.
- Subject has received 3 months of treatment with the modified FOLFIRINOX regimen.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwest Community Healthcare Coordinator of this site? Confirm its status | Arlington Heights | United States | Unknown status |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| St. Luke's Cancer Center Coordinator of this site? Confirm its status | Easton | United States | Unknown status |
| Norton Healthcare Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Miami Cancer Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of South Florida/Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.