NCT01237171撤回不适用
Outcome Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage NSCLC
IsoRay Medical, Inc.1 个研究点 分布在 1 个国家开始时间: 2010年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Local Recurrence
研究概览
简要总结
For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of lung may leave too little lung behind for easy breathing. For some of these patients, it may be possible to perform a smaller-scale surgery ("sub-lobar resection") and place a radioactive implant behind to prevent the cancer from growing back. This study will see how these patients do in terms of controlling their disease treated with a radioactive implant called Cesium-131.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have suspicious lung nodule for clinical stage I/recurrent non-small cell Lung Cancer
- •Mass Tumor size < 7 cm
- •Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration.
- •Patient must have ECOG/Zubrod performance status 0,1, or 2.
排除标准
- •Patient has already received high dose radiation to the area
- •Cancerous nodule is very close to the esophagus or spinal cord, thereby increasing the risk of radiation treatment
- •Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)
结局指标
主要结局
Local Recurrence
时间窗: 3 Years
Cancer regrowth in the area where it was surgically removed
次要结局
- Quality of Life(2 years)
研究者
研究点 (1)
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