Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer
This pilot clinical trial studies how well radiofrequency ablation works in treating patients with stage IA non-small cell lung cancer. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Computed tomography (CT)-guided radiofrequency ablation may be a better treatment for non-small cell lung cancer.
Checked against the public recordLast updated Mar 8, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UAB Comprehensive Cancer CenterBirmingham, Alabama
- Jonsson Comprehensive Cancer Center at UCLALos Angeles, California
- University of California Davis Cancer CenterSacramento, California
- Massachusetts General HospitalBoston, Massachusetts
- Boston University Cancer Research CenterBoston, Massachusetts
- William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan
- Stony Brook University Cancer CenterStony Brook, New York
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina
- Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio
- Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon
- Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island
- H. Clay Evans Johnson Cancer Center at Memorial HospitalChattanooga, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 8, 2017. Always confirm current availability with the study team.