Cryotherapy in Treating Patients With Lung Cancer

Primary Outcome Measures:

• Safety of interventional cryoablation to the lung [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).

Secondary Outcome Measures:

• Local control measured by imaging [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
  Measure definitions:
  • Complete Response(tumor disappearance or less than 25% of original size)
  • Partial Response (greater than 30% decrease in the sum of the largest diameter of all targeted tumors)
  • stable Disease (less than 30% decrease in the sum of the largest diameter of all targeted tumors)
  • Local Failure (greater than 20% increase in the sum of the largest diameter of all targeted tumors)
  • Distant Failure (the appearance of distant cancer deposits consistent with metastatic spread of cancer outside the intended treatment area)
• Physical function and quality of life [ Time Frame: At baseline and 1, 3, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  Measured by ECOG and KPS performance status, the Short Form – 12v2 questionnarie and shory physical performance battery
• Changes in pulmonary function [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
  Measure by pulmonary function test
• Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial [ Time Frame: At 1 week and 1, 3, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]

Detailed Description:

Primary Objectives:

1. 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:

1. Estimate local control.
2. To assess physical function for this cohort of patients.
3. To evaluate the impact of treatment on generic and disease-specific quality of life.
4. To obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial.
5. 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.

Eligibility Criteria

Inclusion Criteria:

• Patients with American Joint Committee on Cancer (AJCC) seventh edition metastatic carcinoma or sarcoma involving the lungs or pleura.
• Pathologic diagnosis of stage 4 cancer prior to enrollment by biopsy or on imaging with known (biopsied) primary disease
• The target lesion is determined (by CT or magnetic resonance imaging [MRI] images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures
• Maximum number of lesions per patient will be 5 total (a maximum of 3 on either the right or left side and 2 lesions on the respective contralateral side)
• Of these, any lesion not treated with cryoablation will be planned to be treated with radiotherapy or radiofrequency ablation, such that all known active pulmonary disease is planned to be treated with a definitive local therapy
• If treatment of both lungs is to occur by cryoablation, these treatments must be separated by at least one week
• The lesion(s) treated with cryoablation may be intrapulmonary or pleural and must be =< 3.5 cm in greatest dimension
• All patients are required to have been evaluated either in consultation with a radiation oncologist or at least in a multi-disciplinary tumor conference to ensure that all local therapy options are appropriately considered for each patient
• Performance Status 0-2 (Eastern Cooperative Oncology Group [ECOG]); Karnofsky Performance Scale >= 60
• Life expectancy > 3 months
• Clinically suitable for cryoablation procedure as determined by the treating physician
• Platelet count > 50,000/mm^3 within 60 days prior to study registration
• International normalized ratio (INR) < 1.5 within 60 days prior to study registration
• Absolute neutrophil count (ANC) < 1000 within 21 days prior to study registration
• A signed study specific consent form is required

Exclusion Criteria:

• Primary lung cancer
• Unable to lie flat or has respiratory distress at rest
• Uncontrolled coagulopathy or bleeding disorders
• Evidence of active systemic, pulmonary, or pericardial infection
• Pregnant, nursing or wishes to become pregnant during the study
• Debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up
• Currently participating in other experimental studies that could affect the primary endpoint