Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT03484299
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Pancreas Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irreversible Electroporation (IRE) — PROCEDURE
    Non-thermal ablation of tumor
  • Gemcitabine — DRUG
    25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
  • FOLFIRINOX — DRUG
    25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

Study Details

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

Key Dates

Start date
May 30, 2018
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Treatment
    Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)

Primary Outcome 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Robert Martin, MD, PhD
[email protected]
502-629-3355
Robert Martin, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Louisville, KY

By research site
University of Louisville· Louisville, KY

Related Studies