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Trial record 1 of 1 for:    03484299
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Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03484299
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville

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

Condition or disease Intervention/treatment Phase
Pancreas Cancer Procedure: Irreversible Electroporation (IRE) Drug: Gemcitabine Drug: FOLFIRINOX Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects undergoing IRE will receive treatment with either FOLFIRINOX or gemcitabine (based on which regimen was received prior to IRE)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Treatment
Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Adverse and Serious Adverse events will be collected and analyzed


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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484299


Contacts
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Contact: Traci Hayat, RN 502-629-3383 traci.hayat@louisville.edu

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Traci Hayat, RN    502-629-3383    traci.hayat@louisville.edu   
Principal Investigator: Robert Martin, MD, PhD         
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Robert Martin, MD, PhD University of Louisville
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Robert C. Martin, Principal Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT03484299    
Other Study ID Numbers: 17.0529
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
 Gemcitabine
Folfirinox
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs