RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery. PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery.
OBJECTIVES: * Estimate the local and distant failure rates after percutaneous thoracic cryotherapy (PTC) in patients with unresectable primary lung cancer or lung metastases. * Estimate rates of PTC complications and adverse reactions. * Determine the correlations between procedural parameters and follow-up imaging parameters, with the latter being used as surrogates of local and/or distant treatment failure. OUTLINE: Patients undergo CT-guided percutaneous thoracic cryotherapy over 2 hours under local or general anesthesia. Grouped cryoprobes are inserted into the tumor, utilizing a freeze-thaw-freeze cycle, creating cytotoxic temperatures (less than -20°C to -40°C) that encompass the entire anticipated tumor volume. Patients undergo positron emission tomography at baseline and after cryotherapy to assess tumor standard uptake variable. After completion of study treatment, patients are followed at 1, 3, 6 and 12 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Local Failure Rates by CT Scan
Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Time frame: at 3, 6, and 12 months
Distant Failure Rate
Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Time frame: at 3, 6, and 12 months
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Rate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity.
Time frame: at 3, 6, and 12 months
Correlate Procedural Parameters and Follow-up Imaging Parameters
Time frame: at 3, 6, and 12 months
Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures
Time frame: 12 months after the last patient was enrolled
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