A Study Investigating How to Avoid Cardiac Toxicity in Lung Cancer Patients Treated With Curative-intent Radiotherapy to Improve Survival, Funded by Yorkshire Cancer Research
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The effect of radiation dose to the heart assessed using blood test (lipids & cholesterol - LDL & HDL levels)
研究概览
简要总结
Radiotherapy plays a major role in the treatment of lung cancer and recent advances in radiotherapy have led to better cure rates. However, the radiotherapy dose needed to destroy the cancer cells can unfortunately also damage the surrounding organs, such as the heart. The precise mechanism of damage and which areas of the heart are more sensitive to radiation is not currently known. This project uses the analysis of large amounts of existing radiotherapy treatment data to determine this. Establishing detailed radiotherapy dose limits for the heart and the heart's sub-structures will lead to the delivery of heart-sparing radiotherapy, where possible, in lung cancer patients treated in Yorkshire and Greater Manchester. The investigators estimate that this should lead to an improvement in one-year survival of approximately 10%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 clinical diagnosis of lung cancer (Stage I-III non-small cell and small cell lung cancer) suitable for curative-intent radiotherapy
- •Patients suitable for curative-intent radiotherapy (minimum 20 fractions for conventional fractionation and 3-8 fractions for SABR)
- •Life expectancy > 4 months
- •Age ≥ 18 years
- •Patient has read and understood the participant information sheet and given informed consent
- •Exclusion criteria:
- •No histological or clinical diagnosis of lung cancer (Stage I-III non-small cell and small cell lung cancer) and not suitable for curative-intent radiotherapy
- •Patients not suitable for curative-intent radiotherapy (minimum 20 fractions for conventional fractionation and 3-8 fractions for SABR)
- •Life expectancy < 4 months
- •Age < 18 years
- •Patient has not read and understood the participant information sheet and has not given informed consent
排除标准
- 未提供
结局指标
主要结局
The effect of radiation dose to the heart assessed using blood test (lipids & cholesterol - LDL & HDL levels)
时间窗: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using lipid \& cholesterol (LDL \& HDL) measurements at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using blood test (brain natriuretic peptide)
时间窗: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using brain natriuretic peptide measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using cardiac imaging (cardiac CT)
时间窗: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using cardiac CT scans at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the cardiac CT scan measured during the study: coronary calcium score (Agaston/Volume) - CAC-RDS 0, CAC-RDS 1, CAC-RDS 2, CAC-RDS 3, CAC-RADS classification.
The effect of radiation dose to the heart assessed using blood test (troponin)
时间窗: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using troponin measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using blood test (C-reactive protein)
时间窗: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using C-reactive protein measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using cardiac imaging (12-lead ECG)
时间窗: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using 12-lead ECG at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the ECG measured during the study: heart rate, rhythm, P wave, QRS complex, QT interval, ST segment \& PR interval.
The effect of radiation dose to the heart assessed using blood test (full blood count)
时间窗: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using full blood count measurement at the following time points (before radiotherapy, within 7 days post-radiotherapy and at 4 months post-radiotherapy)
The effect of radiation dose to the heart assessed using cardiac imaging (cardiac ultrasound)
时间窗: 4 months (duration of each participant on study)
The effect of radiation dose to the heart assessed using cardiac ultrasound scans at the following time points (before radiotherapy and at 4 months after radiotherapy). The following components of the cardiac ultrasound measured during the study: parasternal long axis, parasternal short axis, apical 2/4/5 chambers, apical long axis, subcostal and parasternal notch.
次要结局
未报告次要终点
研究者
Prof Corinne Faivre-Finn
Professor of thoracic radiation oncology
The Christie NHS Foundation Trust