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

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer
Eligibility Criteria
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)
Sites / Locations
- UAB Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center at UCLA
- University of California Davis Cancer Center
- Massachusetts General Hospital
- Boston University Cancer Research Center
- William Beaumont Hospital - Royal Oak Campus
- Stony Brook University Cancer Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Good Samaritan Hospital Cancer Treatment Center
- Providence Cancer Center at Providence Portland Medical Center
- Rhode Island Hospital Comprehensive Cancer Center
- H. Clay Evans Johnson Cancer Center at Memorial Hospital
- Medical City Dallas Hospital
- Huntsman Cancer Institute at University of Utah
- Providence Cancer Center at Sacred Heart Medical Center
- Providence Cancer Center at Holy Family Hospital
- Medical College of Wisconsin Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (RFA therapy)
A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo RFA directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.