Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Pancreas Cancer Clinical Trial

Official title:

Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03484299
• Other study ID #: 17.0529
• Status: Recruiting
• Phase: Phase 1
• Start date: May 30, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: University of Louisville
• Contact: Traci Hayat, RN
• Phone: 502-629-3383
• Email: traci.hayat[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Irreversible Electroporation (IRE)
Non-thermal ablation of tumor

Drug:
• Gemcitabine
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
• FOLFIRINOX
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)	Adverse and Serious Adverse events will be collected and analyzed	Time from first dose until subject has reached 90 days post last active study treatment
Secondary	Progression free survival	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.	Time from first dose date to first date of confirmed disease progression, assessed for 90 days