A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
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).
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
V. Evaluate changes in pulmonary function at 3 months.
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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).
Wake Forest University
United States: Institutional Review Board