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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03484299
Other study ID # 17.0529
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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