NCT00346320已完成不适用
A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 38
- 主要终点
- Local tumor control rate at 2 years
研究概览
简要总结
RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer.
Secondary
- Determine the toxicities of this regimen in these patients.
- Determine the rates of regional and distant disease recurrence in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the changes in pulmonary function after treatment in these patients.
- Assess the quality of life of patients after treatment.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Local tumor control rate at 2 years
时间窗: 2 years
Overall tumor control rate will be assessed at 6 years
次要结局
- Toxicity(6 years)
- Disease recurrence rates(6 years)
- Progression-free survival(6 years)
- Overall survival(6 years)
- Quality of life(6 years)
- Changes in pulmonary function(6 years)
研究者
研究点 (38)
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