Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer
2017年1月26日 更新者：Alliance for Clinical Trials in Oncology
A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA 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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
54
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- UAB Comprehensive Cancer Center
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California
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Los Angeles、California、美国、90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Sacramento、California、美国、95817
- University of California Davis Cancer Center
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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Boston、Massachusetts、美国、02118
- Boston University Cancer Research Center
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Michigan
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Royal Oak、Michigan、美国、48073
- William Beaumont Hospital - Royal Oak Campus
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New York
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Stony Brook、New York、美国、11794-9446
- Stony Brook University Cancer Center
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North Carolina
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Chapel Hill、North Carolina、美国、27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Ohio
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Cincinnati、Ohio、美国、45220
- Good Samaritan Hospital Cancer Treatment Center
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Oregon
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Portland、Oregon、美国、97213-2967
- Providence Cancer Center at Providence Portland Medical Center
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Rhode Island
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Providence、Rhode Island、美国、02903
- Rhode Island Hospital Comprehensive Cancer Center
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Tennessee
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Chattanooga、Tennessee、美国、37404
- H. Clay Evans Johnson Cancer Center at Memorial Hospital
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Texas
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Dallas、Texas、美国、75230
- Medical City Dallas Hospital
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Utah
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Salt Lake City、Utah、美国、84112
- Huntsman Cancer Institute at University of Utah
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Washington
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Spokane、Washington、美国、99204
- Providence Cancer Center at Sacred Heart Medical Center
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Spokane、Washington、美国、99207
- Providence Cancer Center at Holy Family Hospital
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- Medical College of Wisconsin Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Treatment (RFA therapy)
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° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
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Undergo RFA
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Survival at 2 Years
大体时间：2 years from registration
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Percentage of participants who were alive at 2 years.
The 2 year survival was estimated using the Kaplan Meier method.
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2 years from registration
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Time to Local Failure
大体时间：Up to 2 years
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The overall time to local failure was defined as the time from registration to documentation of > local failure.
The local failure was defined as the recurrence in the same lobe or hilum (N1 nodes) or progression at the ablated site after treatment affects have subsided.
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Up to 2 years
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Overall Time to Recurrence
大体时间：Up to 2 years
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The overall time to recurrence was defined as the time from registration to documentation of disease recurrence.
If a patient dies without a documentation of disease recurrence, the patient will be considered to have had tumor recurrence at the time of their death unless there is sufficient evidence to conclude no recurrence occurred prior to death.
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Up to 2 years
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Number of Procedures Deemed Technical Successes
大体时间：Up to 2 years
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The number of procedures deemed technical successes is defined as the number of patients with a RFA procedures deemed a technical success.
A technical success is defined as follows: The pertinent captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g.
impedance, current, power, treatment time and maximum intra-tumoral temperature) were reviewed by the quality control panel to determine technical success.
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Up to 2 years
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Incidence of Adverse Events
大体时间：Up to 2 years
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The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate adverse event.>
Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
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Up to 2 years
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Change in Pulmonary Function From Baseline at Month 3
大体时间：Baseline and Month 3
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Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO).
The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 3 was summarized.
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Baseline and Month 3
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Change in Pulmonary Function From Baseline at Month 24
大体时间：Baseline and Month 24
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Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO).
The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 24 was summarized.
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Baseline and Month 24
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年9月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2013年2月1日
研究注册日期
首次提交
2005年5月3日
首先提交符合 QC 标准的
2005年5月3日
首次发布 (估计)
2005年5月4日
研究记录更新
最后更新发布 (实际的)
2017年3月8日
上次提交的符合 QC 标准的更新
2017年1月26日
最后验证
2017年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
肺癌的临床试验
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Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung） | 药物相关副作用和不良反应（MeSH术语） | 表皮生长因子受体酪氨酸激酶抑制剂台湾
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Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤（皮肤癌） | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung）意大利