Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer

Inclusion Criteria:

• PRE-REGISTRATION CRITERIA:
• Patients must have a lung nodule suspicious for clinical stage I non-small cell lung cancer (NSCLC)
• Patient must have a mass =< 3 cm maximum diameter by CT size estimate: clinical stage IA
• Patient must have been evaluated by a thoracic surgeon and been deemed at high risk for a lung resection; NOTE: if the evaluating surgeon is not a member of American College of Surgeons Oncology Group (ACOSOG), then an ACOSOG thoracic surgeon must confirm with dated signature that the patient is high-risk and appropriate for RFA
• Patient must have fludeoxyglucose F 18 (FDG)-PET and a CT scan of the chest with upper abdomen within 60 days prior to pre-registration; patient must have pulmonary function tests (PFTs) within 120 days prior to registration
• Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2

• Patient must meet at least one major criterion or meet a minimum of two minor criteria as described below:

  • Major criteria

    • Forced expiratory volume in one second (FEV1) =< 50% predicted
    • Diffusing capacity of the lung for carbon monoxide (DLCO) =< 50% predicted

  • Minor Criteria

    • Age >= 75
    • FEV1 51-60% predicted
    • DLCO 51-60% predicted
    • Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
    • Poor left ventricular function (defined as an ejection fraction of 40% or less)
    • Resting or exercise arterial partial pressure of oxygen (pO2) =< 55 mmHg or oxygen saturation (SpO2) =< 88%
    • Partial pressure of carbon dioxide (pCO2) > 45 mmHg
    • Modified Medical Research Council (MMRC) Dyspnea Scale >= 3
• Patient must not have had previous intra-thoracic radiation therapy
• Women of child-bearing potential must have negative serum or urine pregnancy test within 2 weeks of registration
• REGISTRATION ACTIVATION CRITERIA:
• Patient must have histologically or cytologically proven NSCLC, 3 cm or smaller, as determined by the largest dimension on CT lung windows
• Patient's tumor must be non-contiguous with vital structures: trachea, esophagus, aorta, aortic arch branches and heart and lesions must be accessible via percutaneous transthoracic route
• Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on PET scan) assessed by the following to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound-guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)