Description:
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.
Clinical Trials /
Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
NCT03484299
Related Conditions:
- Pancreatic Carcinoma
Recruiting Status:
Recruiting
Phase:
Phase 1
Trial Eligibility
Document
Title
- Brief Title: Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
- Official Title: Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma
Clinical Trial IDs
- ORG STUDY ID: UL 2017.1
- NCT ID: NCT03484299
Conditions
- Pancreas Cancer
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| Gemcitabine | Treatment | |
| FOLFIRINOX | Treatment |
Purpose
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or
gemcitabine in patients with locally advanced pancreatic cancer.
Detailed Description
Phase II study in which all patients undergoing IRE for the treatment of locally advanced
pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation
treatment.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| Treatment | Other | Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE) |
|
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability) |
| Time Frame: | Time from first dose until subject has reached 90 days post last active study treatment |
| Safety Issue: | |
| Description: | Adverse and Serious Adverse events will be collected and analyzed |
Secondary Outcome Measures
| Measure: | Progression free survival |
| Time Frame: | Time from first dose date to first date of confirmed disease progression, assessed for 90 days |
| Safety Issue: | |
| Description: | Triphase CT scan will be performed within one month of IRE procedure. Triphase CT scans will then be obtained every 3 months to check disease status. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | University of Louisville |
Last Updated
August 2, 2021
