A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer
Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
Study start date: September 1, 2006
Actual date on which the first participant was enrolled.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 freedom from local recurrence in the ablated lobe. III. To estimate the number of procedures deemed technical successes. IV. To evaluate procedure-specific morbidity and mortality. V. To explore the utility of immediate (within 96 hours) post-RFA positron emission tomography (PET) in predicting overall survival and local control. VI. To explore the effect of RFA on both short-term (3 months post-RFA) and long-term (24 months post-RFA) pulmonary function. OUTLINE: 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° Celsius (C). Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.54 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 17 locations
UAB Comprehensive Cancer Center
Birmingham, United StatesOpen UAB Comprehensive Cancer Center in Google MapsJonsson Comprehensive Cancer Center at UCLA
Los Angeles, United StatesUniversity of California Davis Cancer Center
Sacramento, United StatesMassachusetts General Hospital
Boston, United States