Status:
COMPLETED
Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the overall 2-year survival rate after radiofrequency ablation (RFA). SECONDARY OBJECTIVES: I. To assess freedom from regional or distant recurrence. II. To assess ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00109876
Start Date
September 1 2006
End Date
February 1 2013
Last Update
March 8 2017
Active Locations (17)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
3
University of California Davis Cancer Center
Sacramento, California, United States, 95817
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114