NCT00238602已完成1 期
Evaluation of the Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Tumors - A Phase I/II Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors
研究概览
简要总结
This study has two primary objectives. The first objective is to determine the maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors. Once the MTD is established, the second objective is to determine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •1.Lung tumor >= 5.0 cm.
- •2.Age > 18 years,
- •3.Histologic confirmation of malignancy (primary lung or metastatic tumor)
- •4.Deemed unresectable either by radiographic criteria (such as direct invasion of the mediastinum, heart, great vessels, or trachea), by virtue of excessive risk to patient, patient refusal to undergo surgery, or prior operative findings.
- •5.Performance status of 0-2 by Eastern Clinical Oncology Group criteria
排除标准
- •No chemotherapy within 2 weeks of radiation treatment.
- •2. Refusal to sign informed consent.
- •3. Refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential.
结局指标
主要结局
Maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors
Efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses
次要结局
未报告次要终点
研究者
研究点 (2)
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