Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
NCT ID: NCT03484299
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2018-05-30
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)
Irreversible Electroporation (IRE)
Non-thermal ablation of tumor
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
Interventions
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Irreversible Electroporation (IRE)
Non-thermal ablation of tumor
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Louisville
OTHER
Responsible Party
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Robert C. Martin
Principal Investigator
Principal Investigators
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Robert Martin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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University of Louisville
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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17.0529
Identifier Type: -
Identifier Source: org_study_id
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