NCT01051037已完成不适用
Phase II Study Evaluating Safety and Efficacy of Stereotactic Body Radiotherapy and Radiofrequency Ablation for Medically Inoperable and Recurrent Lung Tumors Near Central Airways
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Achieve at most of 20% subacute or chronic grade 3 or higher lng, cardiac, or upper GI toxicity rate in patients treated with SBRT/RFA.
研究概览
简要总结
The purpose of this study is to demonstrate that combined stereotactic body radiotherapy and radiofrequency ablation is safe for patients with lung tumors near central airways.
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
- •Histologically confirmed primary lung cancer, lung metastasis from another primary, or recurrent tumors in the setting of prior RFA or cryotherapy
- •Tumors < 2 cm from trachea or zone of proximal bronchial tree (central tumors)
- •Each tumor < 5 cm in size prior to treatment
- •Medically inoperable patients as determined at the multidisciplinary thoracic tumor board, or medically operable patients who refuse surgery
- •Criterion for medical inoperability include:
- •Overall clinical assessment at the UCLA thoracic tumor board
- •Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below:
- •Modified ACOSOG Criteria for medical inoperability:
- •Major Criteria: FEV1% < 50% or < 1L and DLCO < 50%
- •Minor Criteria: Age > 75, FEV1 51-60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF < 40% or less), resting or exercise arterial pO2 < 55 mmHg, and pCO2 > 45 mmHg
- •Age > 18 years old
- •KPS > 70
- •If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Prior thoracic radiation near the targets of interest
- •More than 2 central tumor targets per patient
- •Active infections requiring systemic antibiotics
结局指标
主要结局
Achieve at most of 20% subacute or chronic grade 3 or higher lng, cardiac, or upper GI toxicity rate in patients treated with SBRT/RFA.
时间窗: 3 years
次要结局
- Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury(3 years)
- Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA.(3 years)
- Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable).(3 years)
- Progression-free survival(3 years)
- Overall survival(3 years)
- Concentration of serum VEGF as an early biomarker for response(3 years)
研究者
研究点 (2)
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