Combining chemotherapy with irreversible electroporation for advanced pancreatic cancer
Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma
This study is testing if combining a special treatment called irreversible electroporation with chemotherapy can help people with advanced pancreatic cancer feel better and manage their disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT03484299 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate the effectiveness and tolerability of irreversible electroporation (IRE) combined with either FOLFIRINOX or gemcitabine in patients diagnosed with locally advanced pancreatic adenocarcinoma. Participants will undergo IRE as a treatment method, followed by chemotherapy as a peri-ablation treatment. The study will assess how well these combinations work in managing the disease and the side effects experienced by patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage III pancreatic cancer and measurable tumors.
Not a fit: Patients currently participating in another cancer treatment trial or those with certain medical implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced pancreatic cancer.
How similar studies have performed: While the combination of IRE with chemotherapy is being explored, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * greater than or equal to 18 years of age * diagnosed with stage III pancreatic cancer * tumor is measurable * GFR \> mL/min/1.73m2 * willing and able to comply with protocol requirements * AST/ALT \>3 times upper limit of normal * stable surgical post-operative course as defined by operative surgeon Exclusion Criteria: * participating in another clinical trial for the treatment of cancer at the time of screening * pregnant or currently breast feeding * have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure * have non-removable implants with metal parts within 1 cm of the target lesion * had a myocardial infarction within 3 months prior to enrollment
Where this trial is running
Louisville, Kentucky
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Robert Martin, MD, PhD — University of Louisville
- Study coordinator: Robert Martin, MD, PhD
- Email: robert.martin@louisville.edu
- Phone: 502-629-3355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.