Determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (immune checkpoint inhibitors) in adult patients with metastatic NSCLC with liver metastases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
24-45 Gy delivered in 3-5 fractions to 1-4 lesions.
200 mg every 3 weeks or 400 mg every 6 weeks
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
RECRUITINGPercentage of patients who receive all fractions of radiotherapy as planned
Feasibility determination. Analyzed with descriptive statistics.
Time frame: Up to 0.5 years after start of study treatment
Proportion of patients who develop grade 3 or higher toxicity
Any serious adverse event that occurs within 60 days after treatment with SBRT or after this time frame and is considered related to the study treatment will also be reported. Analyzed with descriptive statistics.
Time frame: Up to 1 year after start of study treatment
Progression-free survival
PFS defined as the time from start of treatment to date of radiological or clinical progression (leading to withdrawal from the study), or death from any cause, whichever comes first. Assessed Per RECIST v1.1; analyzed using Kaplan-Meier curves and descriptive statistics.
Time frame: Time Frame: Up to 3 years after end of study treatment
Overall survival (OS)
OS defined as the time from start of treatment to death. This will be analyzed using Kaplan-Meier curves and descriptive statistics.
Time frame: Time Frame: Up to 3 years after end of study treatment
Proportion of patients with local control
Freedom from local progression (local control) is defined as the lack of progression of the tumors treated by RT, either by tumor size or enhancement. Progression or development of new tumors elsewhere in the liver or outside of the liver would not constitute a local control failure. Tumors which increase in size or demonstrate new or increasing enhancement are considered progression. Analyzed using Kaplan-Meier curves and descriptive statistics.
Time frame: Time Frame: Up to 3 years after end of study treatment
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