Radiotherapy for Stage I-III Non-small Cell Lung Cancer to an Individualized MLD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- death
研究概览
简要总结
Our group has shown in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP. In a subsequent phase I trial, the investigators showed the safety of this approach. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for radical radiotherapy
详细描述
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to the following MLD (Mean Lung Dose):
- MLD=19 Gy when Fev1 and DLCO > 50% of the predicted value
- MLD=15 Gy when Fev1 and/or DLCO 40-49% of the predicted value
- MLD=10 Gy when Fev1 and/or DLCO <40% of the predicted value
Other dose-constrains: spinal cord max: 54 Gy, brachial plexus (Dmax):66 Gy Minimum tumor dose:79.2 Gy.
Radiotherapy will be delivered in twice-daily fractions of 1.8 Gy with 8 to 10 h as interfraction-interval, 5 days per week.
The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histological or cytological proven NSCLC
- •UICC stage I-III
- •Performance status 0-2
- •FeV 1 and DLCO at least 30% of the age-predicted value
排除标准
- •Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
- •UICC stage IV
- •Performance status 3 or more
- •FeV 1 and DLCO < 30% of the age-predicted value
结局指标
主要结局
death
时间窗: 2,3 and 5 years
次要结局
- -progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence(2,3 and 5 years)