Lung Function After Curatively Intended Radiotherapy for Non-small-cell Lung Carcinoma, -Changes and Predictive Markers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- permanently reduced lung function
研究概览
简要总结
Aims:
- Evaluate changes in lung function before and after radiotherapy for patients with NSCLC in stage I-III receiving curatively intended radiotherapy
- To assess the predictive value of pulmonary function tests for the development of radiation pneumonitis after curative radiotherapy
- To assess biomarkers in blood samples before, during, and after radiotherapy and correlate to the development of radiation pneumonitis
- Investigate survival
详细描述
This prospective longitudinal study planned to include 70 patients with NSCLC in stages I-III who will be its own control group for changes in lung function.
It will be included patients destined to have stereotactic or concomitant chemoradiotherapy in curative intent.
Follow-up will include a physical examination by a pulmonologist, spirometry, determination of the diffusion capacity for carbon monoxide (DLCO), determination of the total lung capacity (TLC), residual volume (RV) and intrathoracic gas volume (ITGV) by body plethysmography, determination of the partial pressure of carbon dioxide (PaCO2) and oxygen (PaO2) by arterial blood gas analysis, the six-minute walking test, the Clinical COPD questionnaire, X-ray and CT scans and blood sample analysis at baseline, 4 to 6 weeks after treatment, and every 3 months thereafter until 12 months after SBRT.
Part of the project is to take blood samples. Specific blood samples will be analyzed to identify biomarkers that could predict the development of radiation-induced lung changes.
Unfortunately, fewer patients than planned were included.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age > 18 years old
- •Current lung cancer, not older than 8 weeks
- •Received written consent
- •Non small cell lung cancer
- •Stage IA-IIIA
- •Inoperable
排除标准
- •Lack of consent
- •Additional cancer disease
- •Small cell lung carcinoma or neuroendocrine lung cancer
结局指标
主要结局
permanently reduced lung function
时间窗: 2 years
次要结局
- predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy(2 years)
研究者
Janna Berg
consultant
Sykehuset i Vestfold HF