Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With IMRT for Stage I-III Non-small Cell Lung Cancer to an Individualised MLD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.
详细描述
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/-1Gy, irrespective of lung function.
Other dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy
In concurrence with chemotherapy, radiotherapy will be delivered as follows:
- First three weeks/30 fractions: twice-daily fractions of 1.5Gy, with 8h to 10h as interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions
- Thereafter: once daily fractions of 2.0Gy, 5 days per week until the target dose has been reached.
In sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction interval of at least 8h will be delivered.
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
- •Histological or cytological proven NSCLC
- •IUCC stage I-III, or solitary metastases (<6), which are amendable for radical local treatment.
- •Performance status 0-2
- •IMRT technique
排除标准
- •Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
- •Stage IV, except for solitary (<6) metastases
- •Performance status 3 or more
- •No IMRT technique
结局指标
主要结局
Overall survival
时间窗: 2.3 and 5 years
次要结局
- Progression-free survival(2.3 and 5 years)
- Dyspnea (CTCAE 4.0)(2.3 and 5 years)
- Dysphagia (CTCAE 4.0)(2.3 and 5 years)
- Patterns of recurrence(2.3 and 5 years)