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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
Be older than 18 years old
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
Summary
This trial compares chemotherapy alone to chemotherapy plus an electrical pulse treatment in patients who have responded well to initial chemotherapy. The goal is to see if adding the electrical pulse treatment can better destroy cancer cells. Electrochemotherapy is a method that uses electric pulses to increase the uptake and effectiveness of chemotherapeutic drugs in cancer cells.
Eligible Conditions
- Stage III Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time (in months) from randomization to the date of death for any reason, assessed through at least 24 months.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival
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
23 Previous Clinical Trials
1,819 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You can't handle being put to sleep with a strong muscle relaxant.You are currently bleeding, taking blood thinners, or have low levels of hemoglobin, white blood cells, or platelets.You have a pacemaker or other electronic devices in your chest.You have a history of epilepsy or other brain-related conditions.You have kidney, heart, liver, or blood problems that the doctor is worried about.You have severe chronic kidney disease in stage 3, 4, or 5.You are currently undergoing a procedure called IRE to enhance the edges of a treatment area.You are currently taking part in another research study for pancreatic cancer.You did not have the right kind of treatment for the study at the end of 3 months.Your tumor is at an advanced stage according to the NCCN guidelines.If your condition gets worse after 3 months of FOLFIRINOX treatment, you cannot participate.The size of your tumor is no larger than 3.5cm after three months of treatment with a specific chemotherapy regimen.You are in good enough physical shape to perform daily activities without restriction (ECOG performance status of 0 or 1).You have been diagnosed with stage 3 pancreatic adenocarcinoma that cannot be removed with surgery.You have already been treated with the modified FOLFIRINOX regimen for 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: IRE
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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