Adaptive Radiotherapy for Stage II-III Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Proportion of patients able to receive 69Gy as TTD
研究概览
简要总结
The investigators group uses an individualised radiation dose approach in which the dose is escalated up to pre-defined tissue constraints (see below). The target dose to the tumor is 69Gy. However, this dose cannot be reached in approximately 30% of the patients, even with an IMRT (Intensity Modulated Radiotherapy) technique, because the MLD (Mean Lung Dose) constraint of 20Gy is reached at a TTD (Total Treatment Dose) below 69Gy. In this study, the investigators will adapt the treatment by performing a new (PET)-CT at day 12 during radiotherapy and in case of a decreased Planning Target Volume (PTV), the dose mey be increased.
详细描述
Eligible patients will receive concurrent chemo-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 concurrent 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
- •UICC 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 of mixed NSCLC and other histologies (e.g. small cell carcinoma)
- •Stage IV, except for solitary (<6) metastases
- •Performance status 3 or more
研究组 & 干预措施
Radiotherapy
干预措施: Radiotherapy and concurrent chemo-therapy (Other)
结局指标
主要结局
Proportion of patients able to receive 69Gy as TTD
时间窗: 3 months
次要结局
- Overall survival(3 months)
- Progression free survival(3 months)
- Dyspnea (CTCAE 4.0)(3 months)
- Dysphagia (CTCAE 4.0)(3 months)
- Patterns of recurrence(3 months)