Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

Not Applicable

Completed

Interventions: Procedure: cryosurgery
Procedure: positron emission tomography

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
cryosurgery	positron emission tomography	cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery	cryosurgery	cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.

Primary Outcome Measures

Name	Time	Method
Local Failure Rates by CT Scan	at 3, 6, and 12 months	Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Distant Failure Rate	at 3, 6, and 12 months	Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence

Secondary Outcome Measures

Name	Time	Method
Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures	12 months after the last patient was enrolled
Correlate Procedural Parameters and Follow-up Imaging Parameters	at 3, 6, and 12 months
Rate of Complications and Adverse Reactions by Occurrences of Toxicities	at 3, 6, and 12 months	Rate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity.