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Recruiting NCT03484299

Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Phase I Interventional Pancreas Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Irreversible Electroporation (IRE), Gemcitabine, FOLFIRINOX.
Who it may be relevant to
Registry conditions: Pancreas Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Progression free survival [Time frame: Time from first dose date to first date of confirmed disease progression, assessed for 90 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Louisville — Louisville

Publications

  • Bhutiani N, Li Y, Zheng Q, Pandit H, Shi X, Chen Y, Yu Y, Pulliam ZR, Tan M, Martin RCG 2nd. Electrochemotherapy with Irreversible Electroporation and FOLFIRINOX Improves Survival in Murine Models of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2020 Oct;27(11):4348-4359. doi: 10.1245/s10434-020-08782-2. Epub 2020 Jul 17. PMID 32681477

Identifiers

NCT: NCT03484299 · 17.0529

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗