A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 34
- 主要终点
- Overall Survival at 2 Years
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
结局指标
主要结局
Overall Survival at 2 Years
时间窗: 2 years from registration
Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.
次要结局
- Overall Time to Recurrence(Up to 2 years)
- Overall Time to Local Failure(Up to 2 years)
- Change in Pulmonary Function From Baseline at Month 24(Baseline and Month 24)
- Incidence of Adverse Events(Up to 2 years)
- Change in Pulmonary Function From Baseline at Month 3(Baseline and Month 3)
- Number of Procedures Deemed Technical Successes(Up to 2 years)