CompletedEarly Phase 1

A Novel Method for Treating Lung Met w/Combo of Electric Fields & Rad Therapy: A Single-Arm

United States6 participantsStarted 2023-01-03

Plain-language summary

This is a phase 0, pilot prospective study to determine the feasibility of combined irreversible electroporation (IRE) and radiation therapy in subjects with lung tumors with metastatic cancer of any histology. These are subjects who have advanced disease (stage IV) or previously treated disease that has become progressive, recurrent, or metastatic.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Platelets ≥50,000/mcL
✓. Hemoglobin ≥8 g/dL
✓. Absolute neutrophil count ≥1,000/mcL
✓. INR \<1.5
✓. Has not undergone a hysterectomy or bilateral oophorectomy; or
✓. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

What they're measuring

Feasibility, measured as the number of patients completing both IRE and the single fraction of radiation

Timeframe: Up to 3 years

Trial details

NCT IDNCT05555342

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-29

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