Radiation Dose Escalation For Non-Small Cell Lung Cancer Using Hypofractionated 3-Dimensional Conformal Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor over a shorter period of time may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying the side effects of hypofractionated 3-dimensional radiation therapy and to see how well it works in treating patients with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the acute and long-term radio-induced toxicity (any organ) of hypofractionated 3-dimensional conformal radiotherapy in patients with newly diagnosed stage I-III non-small cell lung cancer.
Secondary
- To assess the radiological tumor response rate at 3 months after completion of radiotherapy.
- To assess the actuarial freedom from thoracic progression rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 Years（Child, 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
Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy
时间窗: weekly during radiotherapy
Long-term radio-induced toxicity as assessed by the long-term RTOG/EORTC and SWOG (lung) grading system every 3 months for 2 years and then every 6 months thereafter
时间窗: every 3 months for 2 years and then every 6 months thereafter
次要结局
- Tumor response rate (according to WHO response criteria) as assessed by CT scan at 3 months after completion of radiotherapy(at 3 months after completion of radiotherapy)
- Actuarial freedom from thoracic progression rate(ongoing)