This pilot clinical trial studies the side effects of cryotherapy (cryoablation \[CA\]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.
PRIMARY OBJECTIVES: I. Assess the initial safety of the CA for lung tumors less than or equal to 3.5 cm in size including acute toxicity (30 days). SECONDARY OBJECTIVES: I. Estimate local control. II. To assess physical function for this cohort of patients. III. To evaluate the impact of treatment on generic and disease-specific quality of life. IV. To obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial. V. Evaluate changes in pulmonary function at 3 months. OUTLINE: Patients undergo computed tomography (CT)-guided CA After completion of study treatment, patients are followed up at 1 week and 1, 3, 6, 12, 24, 36, 48, and 60 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Undergo CT-guided CA
Ancillary studies
Safety of interventional cryoablation to the lung
Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: 6 months
Local control measured by imaging
Measure definitions: * Complete Response(tumor disappearance or less than 25% of original size) * Partial Response (greater than 30% decrease in the sum of the largest diameter of all targeted tumors) * stable Disease (less than 30% decrease in the sum of the largest diameter of all targeted tumors) * Local Failure (greater than 20% increase in the sum of the largest diameter of all targeted tumors) * Distant Failure (the appearance of distant cancer deposits consistent with metastatic spread of cancer outside the intended treatment area)
Time frame: At 1 year
Changes in Physical function and quality of life
Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery
Time frame: approximately 60 months
Changes in pulmonary function
Measure by pulmonary function test
Time frame: At 3 months
Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial
Time frame: approximately 60 months
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