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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
IRE will be performed using the NanoKnife or Aliya System. CT or cone-beam CT will be used to direct electrode placement.
Moderate-dose radiation therapy to the target tumor(s) in 1 fraction.
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, United States
Feasibility, measured as the number of patients completing both IRE and the single fraction of radiation
Number of patients completing treatment of both IRE and the single fraction of radiation. Up to 6 replacements are allowed (total subjects 6-12)
Time frame: Up to 3 years
Number of grade 3-5 adverse events
Severe toxicity will be measured by cumulative CTCAE v5.0 grade 3-5 events. Evaluation of Grade 3-5 toxicity will be made at 30 days
Time frame: Up to 3 years
Local failure at the treated site
Local failure rate at the treated site will be determined using cumulative incidence rates with death as a competing event at 12 months after initiation of treatment
Time frame: Up to 3 years
Duration of response
The duration of response is measured from the time of treatment initiation until local failure is objectively documented
Time frame: Up to 3 years
Progression-free survival
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Estimates at 6 and 12 months will be made.
Time frame: Up to 3 years
Overall survival
The duration of time from start of treatment to time of progression or death, whichever occurs first. Estimates at 6 and 12 months will be made.
Time frame: Up to 3 years
Number of grade 1-5 adverse events
Toxicity will be measured by cumulative CTCAE v5.0 grade 1-5 events. Evaluation of Grade 1-5 toxicity will be made at 30 days
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Time frame: Up to 3 years
Patient reported quality of life
Mean summary score of the Functional Assessment of Cancer Therapy-Lung (FACT-L). Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale is a 36-item self-reported instrument that measures multidimensional quality of life for lung cancer patients. Questions are scored on a 5-point Likert Scale. The FACT-L includes the FACT-G (general) assessment which is comprised of four subscales including Physical Well-Being (score = 0-28), Social/Family Well-Being (score= 0-28), Emotional Well Being (score = 0-24), and Functional Well-Being (score = 0-28), for a total score min/max = 0-108, plus, the Lung Cancer Subscale (nine lung cancer related items, score = 0-45). Total scores range from 0-136, with higher scores indicating better quality of life.
Time frame: Up to 3 years
Forced vital capacity
Pulmonary function is assessed by the volume change (mL) in the value of forced vital capacity (FVC)
Time frame: Up to 3 years
Forced expiratory volume at 1 second (FEV1)
Pulmonary function is assessed by volume change (mL) in the value of forced expiratory volume at 1 second (FEV1)
Time frame: Up to 3 years
Diffusing capacity for carbon monoxide (DLCO)
Pulmonary function is assessed by change in the value of diffusing capacity for carbon monoxide (DLCO) measured in mL/min/kPa
Time frame: Up to 3 years