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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management

Conditions
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Lung Cancer, Metastatic Cancer

Intervention / Treatment
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* Procedure: cryosurgery
* Procedure: positron emission tomography


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant pulmonary neoplasm New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed Imaging findings compatible with localized treatment failure after prior cryotherapy allowed Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy Metastatic disease must meet all of the following criteria: Primary tumors have been resected or have been deemed controlled by other therapies No other widespread metastases evident (e.g., multiple hepatic or brain metastases) Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach No more than 5 targeted masses for study therapy Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter Unresectable disease by surgical consultation OR patient refused surgical options Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner PATIENT CHARACTERISTICS: Karnofsky performance status (PS) > 60-100% OR WHO/ECOG/Zubrod PS 0-2 FEV_1 > 30% of predicted DLCO > 40% of predicted Platelet count ≥ 70,000/mm^3 INR < 1.5 No uncontrolled coagulopathy or bleeding diathesis Not pregnant or nursing Negative pregnancy test No serious medical illness, including any of the following: Uncontrolled congestive heart failure Uncontrolled angina Myocardial infarction Cerebrovascular event within 6 months prior to study entry No medical contraindication or potential problem that would preclude study compliance PRIOR CONCURRENT THERAPY: At least 7 days since prior aspirin and aspirin-like medications At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate) No concurrent participation in other experimental studies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cryosurgery<br>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. | Procedure: cryosurgery<br> <br> Procedure: positron emission tomography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Failure Rates by CT Scan | Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence | at 3, 6, and 12 months | 
| Distant Failure Rate | Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence | at 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 3, 6, and 12 months | 
| Correlate Procedural Parameters and Follow-up Imaging Parameters |  | at 3, 6, and 12 months | 
| Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures |  | 12 months after the last patient was enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II non-small cell lung cancer, lung metastases, recurrent non-small cell lung cancer, recurrent small cell lung cancer, stage I non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, pulmonary carcinoid tumor