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Chemotherapy

NanoKnife IRE for Pancreatic Cancer (DIRECT Trial)

Phase 3
Recruiting
Research Sponsored by Angiodynamics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Subject has a diagnosis of unresectable Stage 3 pancreatic adenocarcinoma cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time (in months) from randomization to the date of death for any reason, assessed through at least 24 months.
Awards & highlights

DIRECT Trial Summary

This trial will test whether adding IRE to chemotherapy can help people with pancreatic cancer who have completed 3 months of modified FOLFIRINOX chemotherapy and have no evidence of disease progression.

Eligible Conditions
  • Stage III Pancreatic Cancer

DIRECT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are in good enough physical shape to perform daily activities without restriction (ECOG performance status of 0 or 1).
Select...
You have been diagnosed with stage 3 pancreatic adenocarcinoma that cannot be removed with surgery.
Select...
You have already been treated with the modified FOLFIRINOX regimen for 3 months.

DIRECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time (in months) from randomization to the date of death for any reason, assessed through at least 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time (in months) from randomization to the date of death for any reason, assessed through at least 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival

DIRECT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IREExperimental Treatment2 Interventions
Group II: ControlActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NanoKnife System
2017
N/A
~20

Find a Location

Who is running the clinical trial?

Angiodynamics, Inc.Lead Sponsor
22 Previous Clinical Trials
1,834 Total Patients Enrolled

Media Library

Modified FOLFIRINOX Regimen (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03899636 — Phase 3
Pancreatic Cancer Research Study Groups: Control, IRE
Pancreatic Cancer Clinical Trial 2023: Modified FOLFIRINOX Regimen Highlights & Side Effects. Trial Name: NCT03899636 — Phase 3
Modified FOLFIRINOX Regimen (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03899636 — Phase 3

Frequently Asked Questions

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

What are the risks associated with Modified FOLFIRINOX Regimen?

"The safety of the Modified FOLFIRINOX Regimen has been evaluated and it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Texas-Southwestern
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Recent research and studies
~129 spots leftby Mar 2025