A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
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.
Interventional
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).
6 months
Yes
James Urbanic
Principal Investigator
Wake Forest University
United States: Institutional Review Board
CCCWFU 62210
NCT01325753
March 2011
March 2017
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