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

Completed · Not applicable

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00109876

Run by

Alliance for Clinical Trials in Oncology

People needed

54

Starts

2006-09-01

Expected to finish

2013-02-01

Last updated by the study team

2017-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States
• Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University Cancer Research Center — Boston, Massachusetts, United States
• William Beaumont Hospital - Royal Oak Campus — Royal Oak, Michigan, United States
• Stony Brook University Cancer Center — Stony Brook, New York, United States
• Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Good Samaritan Hospital Cancer Treatment Center — Cincinnati, Ohio, United States
• Providence Cancer Center at Providence Portland Medical Center — Portland, Oregon, United States
• Rhode Island Hospital Comprehensive Cancer Center — Providence, Rhode Island, United States
• H. Clay Evans Johnson Cancer Center at Memorial Hospital — Chattanooga, Tennessee, United States
• Medical City Dallas Hospital — Dallas, Texas, United States
• Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah, United States
• Providence Cancer Center at Sacred Heart Medical Center — Spokane, Washington, United States
• Providence Cancer Center at Holy Family Hospital — Spokane, Washington, United States
• Medical College of Wisconsin Cancer Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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