The Value of Echocardiography for Prediction of Radiation-induced Lung Injury in Non-small Cell Lung Cancer Patients Treated With Chemoradiation: an Onco-cardiac Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Dyspnea score at three months after (chemo)radiotherapy, assessed by the patient version of the CTCv4.0
研究概览
简要总结
Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation. In this study the investigators want to evaluate the prognostic value of baseline cardiac function assessed with echocardiography for prediction of RILI.
详细描述
Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation (CRT).This side-effect can heavily impact quality of life and is a dose-limiting factor for the treatment. Identifying high risk patients before the start of the treatment would make it possible to adapt the treatment by choosing another radiation technique or proton therapy. However, despite the fact that many patient and treatment characteristics have been associated with RILI, it is not possible to accurately predict the risk of RILI for individual patients. Recently, it has been shown that the radiation dose to the heart is a risk factor for lung toxicity in both animal and clinical studies. Also, in a study, carried out jointly by CARIM and GROW, it was found that patients with a previous diagnosis of cardiac disease had a significantly higher risk to develop RILI after CRT (p-value <0.001), even with low or no radiation dose to the heart. It is unknown whether asymptomatic cardiac comorbidity is also related to development of RILI. Taking into account that approximately 30% of all lung cancer patients suffer from symptomatic cardiac comorbidity at the start of cancer treatment, there is an urgent need for research projects focusing on cardio-oncology. These projects will make it possible to unravel the complex relationship between heart, lungs, chemotherapy and radiation treatment. In the current project the investigators hypothesize that biomarkers based on echocardiography, which reflects cardiac function, are prognostic for development of radiation induced lung injury after chemoradiotherapy. In addition, the investigators will validate our previous finding that presence of cardiac comorbidity is associated with RILI.
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
- •Clinical stage I-III non small cell lung cancer, excluding malignant pleural/pericardial effusion
- •Planned for curatively intended primary (chemo)radiotherapy, due to irresectable disease and/or medical inoperability
- •WHO performance status 0-2
- •No history of prior chest radiotherapy
- •No uncontrolled infectious disease
- •No other active malignancy
- •No prior lung surgery (VATS, wedge resection, segment resection, lobectomy)
- •Willing and able to comply with the study prescriptions
- •18 years or older
- •Ability to give and having given written informed consent before patient registration
排除标准
- •malignant pleural/pericardial effusion
- •history of prior chest radiotherapy
- •uncontrolled infectious disease
- •other active malignancy
- •prior lung surgery (VATS, wedge resection, segment resection, lobectomy)
结局指标
主要结局
Dyspnea score at three months after (chemo)radiotherapy, assessed by the patient version of the CTCv4.0
时间窗: up to 3 months
次要结局
- Dyspnea score at six months after (chemo)radiotherapy, assessed by the patient version of CTCv4.0(up to 6 months)
- Changes in dyspnea score after radiotherapy, compared to baseline(up to 12 months)
- Lung fibrosis score at 6-months after start of chemo radiation, assessed on a follow-up CT scan image(up to 6 months)
- Prevalence-based dyspnea measure, reflecting severity as well as duration of dyspnea(up to 12 months)
- Inflammatory parameters (CRP, IL-6 and TNFa) in the blood at baseline and during treatment(up to 3 months)
- Change in Left Ventricle Ejection Fraction (LVEF) (baseline versus 3-month after chemo radiation)(up to 3 months)
- Change in left atrial volume (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)(up to 3 months)
- Radiation pneumonitis at 3-months after start of radio(chemo)therapy, assessed on a follow-up 3D CT scan image.(up to 3 months)
- Changes in physical activity levels and sedentary behavior, assessed by accelerometry(up to 12 months)
- Pulmonary function based on spirometry(up to 3 months)
- Change in pulmonary vein inflow patterns (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)(up to 3 months)
- Change in tissue doppler patterns of the mitral annulus (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)(up to 3 months)
- Cardiac blood biomarkers at baseline and during treatment, Brain natriuretic peptide(BNP), troponin I (TnI) and troponin T(TnT)(up to 3 months)
- Change in left atrial ejection fraction (from pts in SR)(2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)(up to 3 months)
- Change in mitral inflow (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)(up to 3 months)
- Haemoglobin parameters in the blood at baseline and during treatment(up to 3 months)
- Time trends in physical activity and sedentary time from baseline till 12 months after radiotherapy, measured by accelerometers in four weekly periods(up to 12 months)