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IRE + Radiation Therapy for Metastatic Lung Cancer
Phase < 1
Waitlist Available
Led By Jeremy Harris, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically or cytologically confirmed metastatic cancer of any histology with a lung tumor present
Patients must not have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that combines two existing treatments: irreversible electroporation and radiation therapy. The trial is for people with lung tumors that have spread to other parts of the body.
Who is the study for?
This trial is for adults over 18 with stage IV or recurrent metastatic cancer that has spread to the lungs. They must have a life expectancy of at least 3 months, be in fair physical condition (ECOG ≤2), and have proper organ function. Participants can't join if they're recovering from side effects of previous cancer treatments, have certain heart conditions, uncontrolled illnesses, are pregnant, or could receive curative treatment elsewhere.Check my eligibility
What is being tested?
The study is testing a new approach combining irreversible electroporation (IRE) ablation and radiation therapy on lung tumors in patients with advanced cancer. It's an early-stage trial to see if this combo is feasible and how well it works when other treatments haven't helped.See study design
What are the potential side effects?
Potential side effects may include skin reactions from radiation, discomfort or complications from IRE such as bleeding or infection at the site of electrode insertion. There might also be general fatigue or changes in blood counts due to the therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread, and I have a tumor in my lung.
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I have never needed steroids for non-infectious lung inflammation.
Select...
My blood tests show my organs and bone marrow are working well.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My cancer is advanced (stage IV) or has come back or spread after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic radiology procedure
Secondary outcome measures
Diffusing capacity for carbon monoxide (DLCO)
Duration of response
Forced expiratory volume at 1 second (FEV1)
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: IRE ablation and radiation therapyExperimental Treatment2 Interventions
Patients will be treated with IRE ablation directed at the target lesion on day 1. Moderate-dose, single-fraction radiation therapy will be delivered to the target lesion on day 8 to day 15.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
543 Previous Clinical Trials
1,922,995 Total Patients Enrolled
Jeremy Harris, MDPrincipal InvestigatorChao Family Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I have another cancer that is getting worse or needs treatment.My cancer has spread, and I have a tumor in my lung.I have never needed steroids for non-infectious lung inflammation.You are expected to live for at least 3 more months.My blood tests show my organs and bone marrow are working well.I have up to 3 cancer lesions suitable for targeted treatment.I am eligible regardless of my gender, race, or ethnicity.I am not pregnant and agree to use birth control.You have not yet healed from side effects caused by previous cancer treatments.My target lesion has been treated with radiation before.I have had treatments for my condition before with no break before starting IRE.I have epilepsy.You have heart rhythm problems, a pacemaker, or a defibrillator implanted.I do not have any unmanaged ongoing illnesses.I am 18 years old or older.My cancer is advanced (stage IV) or has come back or spread after treatment.My condition can potentially be cured with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: IRE ablation and radiation therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any enrolment opportunities in this clinical trial currently available?
"According to the records available on clinicaltrials.gov, this trial is no longer actively recruiting patients. Though it was first posted in December 2022 and last modified a month later, there are 2167 other trials that currently require participants."
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