← Back to Search

Other

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

Must not have

Patient has a known additional malignancy that is progressing or requires active treatment

Patient's target lesion has been previously treated with radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

My cancer has spread, and I have a tumor in my lung.

Select...

I have never needed steroids for non-infectious lung inflammation.

Select...

My blood tests show my organs and bone marrow are working well.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am 18 years old or older.

Select...

My cancer is advanced (stage IV) or has come back or spread after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have another cancer that is getting worse or needs treatment.

Select...

My target lesion has been treated with radiation before.

Select...

I have epilepsy.

Select...

I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic radiology procedure

Secondary study objectives

Diffusing capacity for carbon monoxide (DLCO)

Duration of response

Forced expiratory volume at 1 second (FEV1)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 10Eligibility criteria met