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Chemotherapy

Chemotherapy + IRE for Pancreatic Cancer

Phase 1

Recruiting

Led By Robert Martin, MD, PhD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Greater than or equal to 18 years of age

Diagnosed with stage III pancreatic cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from first dose until subject has reached 90 days post last active study treatment

Awards & highlights

Study Summary

This trial is testing two different combinations of drugs to see which is more effective and has fewer side effects in treating locally advanced pancreatic cancer.

Who is the study for?

This trial is for adults over 18 with stage III pancreatic cancer. Participants must have a measurable tumor, normal liver function (AST/ALT levels within three times the upper limit), and a stable post-surgery condition as confirmed by their surgeon. They should not be in another cancer treatment trial, pregnant or breastfeeding, have certain implants near the lesion, or recent heart attacks.Check my eligibility

What is being tested?

The study compares two treatments for advanced pancreatic cancer: Irreversible Electroporation (IRE) combined with FOLFIRINOX versus IRE with gemcitabine. It aims to see which combination is more effective and tolerable for patients.See study design

What are the potential side effects?

Potential side effects include those from chemotherapy like nausea, fatigue, low blood counts leading to increased infection risk; and from IRE such as abdominal pain, potential damage to nearby organs or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My condition is stage III pancreatic cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from first dose until subject has reached 90 days post last active study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from first dose until subject has reached 90 days post last active study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first dose until subject has reached 90 days post last active study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)

Secondary outcome measures

Progression free survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

FDA approved

FOLFIRINOX

2013

Completed Phase 3

~790

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

339 Previous Clinical Trials

76,660 Total Patients Enrolled

Robert Martin, MD, PhDPrincipal InvestigatorUniversity of Louisville

5 Previous Clinical Trials

18,058 Total Patients Enrolled

Media Library

FOLFIRINOX (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03484299 — Phase 1

Pancreatic Cancer Research Study Groups: Treatment

Pancreatic Cancer Clinical Trial 2023: FOLFIRINOX Highlights & Side Effects. Trial Name: NCT03484299 — Phase 1

FOLFIRINOX (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03484299 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide an overview of prior experiments concerning this therapy?

"Presently, 446 trials are researching this treatment with 134 of them in the third stage. Although Adelaide, South Australia has several related clinical studies, there are 24 565 locations conducting research on it globally."

Answered by AI

Has this treatment received governmental clearance?

"Due to the preliminary nature of this Phase 1 trial, there is a limited amount information regarding safety and efficacy. Thus our team at Power assigns it an estimated risk score of 1."

Answered by AI

Does this research have opportunities for further participant enrollment?

"Affirmative. Clinicaltrials.gov's records confirm that this trial, which was originally announced on May 30th 2018, is actively seeking volunteers to participate in the research. Currently, 20 patients are needed at a single medical facility."

Answered by AI

How many participants have signed up for the experimental program?

"This is accurate. Data found on clinicaltrials.gov illustrates that this clinical trial, first posted to the website on May 30th 2018, is actively seeking participants. 20 individuals are required from 1 medical centre for completion of the study."

Answered by AI

Under what circumstances is this therapeutic intervention typically employed?

"This medical intervention is a popular choice for treating small cell lung cancer (SCLC), and has also been applied to head/neck carcinomas, pancreatic adenocarcinoma of advanced stages, as well as cervical cancers."

Answered by AI

Recent research and studies

Annals of Surgical OncologyJournal

Electrochemotherapy with Irreversible Electroporation and FOLFIRINOX Improves Survival in Murine Models of Pancreatic Adenocarcinoma

Bhutiani, Neal, Yan Li, Qianqian Zheng, Harshul Pandit, Xiaoju Shi, Yujia Chen, Youxi Yu, Zachary R. Pulliam, Min Tan, and Robert C. G. Martin II. 2020. “Electrochemotherapy with Irreversible Electroporation and FOLFIRINOX Improves Survival in Murine Models of Pancreatic Adenocarcinoma”. Annals of Surgical Oncology. Springer Science and Business Media LLC. doi:10.1245/s10434-020-08782-2.

clinicaltrials.govStudy

Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Robert C. Martin 2018. "Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03484299.

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