20 Participants Needed

Chemotherapy + IRE for Pancreatic Cancer

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Overseen ByTraci Hayat, RN
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Louisville
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the combination of chemotherapy and IRE safe for treating pancreatic cancer?

FOLFIRINOX, a chemotherapy regimen used for pancreatic cancer, has been shown to have different safety profiles compared to other treatments like gemcitabine. It can cause more severe side effects such as vomiting, diarrhea, and neutropenia (low white blood cell count), so careful monitoring is important.12345

How does the treatment FOLFIRINOX + Gemcitabine differ from other treatments for pancreatic cancer?

The combination of FOLFIRINOX and Gemcitabine for pancreatic cancer is unique because FOLFIRINOX has shown to improve overall survival compared to Gemcitabine alone, offering a more effective option for patients with metastatic pancreatic cancer.16789

What data supports the effectiveness of the treatment FOLFIRINOX for pancreatic cancer?

Research shows that FOLFIRINOX, a combination of chemotherapy drugs, leads to longer overall survival in patients with metastatic pancreatic cancer compared to gemcitabine, another chemotherapy drug. In a clinical trial, patients treated with FOLFIRINOX lived on average 11.1 months compared to 6.8 months for those treated with gemcitabine.1261011

Who Is on the Research Team?

RM

Robert Martin, MD, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My condition is stage III pancreatic cancer.
My surgeon says my recovery after surgery is going as expected.
Your kidney function is better than a certain level.
See 3 more

Exclusion Criteria

I had a heart attack in the last 3 months.
You have a heart device that cannot be turned off during the procedure.
I have metal implants near my cancer that cannot be removed.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either FOLFIRINOX or gemcitabine as peri-ablation treatment in combination with irreversible electroporation

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Triphase CT scans every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • FOLFIRINOX
  • Gemcitabine
  • Irreversible Electroporation (IRE)
Trial Overview 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.
How Is the Trial Designed?
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)

FOLFIRINOX is already approved in European Union, United States for the following indications:

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Approved in European Union as FOLFIRINOX for:
  • Advanced pancreatic cancer
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Approved in United States as FOLFIRINOX for:
  • Metastatic pancreatic cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

Published Research Related to This Trial

In a phase II trial involving 48 patients with gemcitabine-refractory unresectable pancreatic cancer, modified FOLFIRINOX demonstrated promising efficacy with an objective response rate of 18.8% and a disease control rate of 62.5%.
The treatment was associated with manageable safety concerns, primarily neutropenia (64.6% of patients), but most non-hematologic adverse events were mild, indicating that while effective, careful monitoring for hematologic toxicities is necessary.
Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer.Chung, MJ., Kang, H., Kim, HG., et al.[2020]
In a study of 342 patients with metastatic pancreatic cancer, the FOLFIRINOX chemotherapy regimen significantly improved overall survival (11.1 months) compared to gemcitabine (6.8 months), indicating it is a more effective first-line treatment option.
While FOLFIRINOX showed a higher objective response rate (31.6% vs. 9.4% for gemcitabine), it also resulted in more adverse events, including a 5.4% incidence of febrile neutropenia, highlighting the need to balance efficacy with safety in treatment decisions.
FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer.Conroy, T., Desseigne, F., Ychou, M., et al.[2023]
In a study of 54 patients with advanced pancreatic cancer, S-IROX showed a higher disease control rate (73.7%) compared to modified FOLFIRINOX (mFFX) (62.2%), indicating it may be more effective as a second-line treatment after gemcitabine plus nab-paclitaxel.
Both S-IROX and mFFX had similar overall survival rates (14.2 months for S-IROX and 11.5 months for mFFX) and tolerability, with no significant differences in severe side effects, suggesting both regimens are viable options for patients.
A retrospective comparative study of S-IROX and modified FOLFIRINOX for patients with advanced pancreatic cancer refractory to gemcitabine plus nab-paclitaxel.Saito, K., Nakai, Y., Takahara, N., et al.[2022]

Citations

Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer. [2020]
FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. [2023]
A retrospective comparative study of S-IROX and modified FOLFIRINOX for patients with advanced pancreatic cancer refractory to gemcitabine plus nab-paclitaxel. [2022]
Systemic therapy of advanced pancreatic cancer: has the landscape changed? [2022]
FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. [2023]
Equivalent Efficacy but Different Safety Profiles of Gemcitabine Plus Nab-Paclitaxel and FOLFIRINOX in Metastatic Pancreatic Cancer. [2022]
Comparative Effectiveness of Gemcitabine plus Nab-Paclitaxel and FOLFIRINOX in the First-Line Setting of Metastatic Pancreatic Cancer: A Systematic Review and Meta-Analysis. [2020]
A New Direction for Pancreatic Cancer Treatment: FOLFIRINOX in Context. [2020]
Modified FOLFIRINOX versus CisGem first-line chemotherapy for locally advanced non resectable or metastatic biliary tract cancer (AMEBICA)-PRODIGE 38: Study protocol for a randomized controlled multicenter phase II/III study. [2022]
Improvement of Treatment Outcomes for Metastatic Pancreatic Cancer: A Real-world Data Analysis. [2022]
A retrospective study of patient-tailored FOLFIRINOX as a first-line chemotherapy for patients with advanced biliary tract cancer. [2021]
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