Quantitative Assessment of Radiation-induced Toxicity of the Heart
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 325
- 试验地点
- 2
- 主要终点
- Cumulative cardio-toxicity after 1 or 5 years
研究概览
简要总结
Late side effects in radio(chemo)therapy [R(CH)T] pose a critical limitation to patients' overall survival and quality of life. Even though toxicities of the heart are highly relevant for patients with cancer in the thoracic region, risk stratification models for these toxicities are lacking. In this study, liquid, functional and imaging biomarkers are being investigated for their use in prediction of cardiac toxicity following R(CH)T for patients with thoracic malignancies.
详细描述
79 patients with non-small cell lung or esophageal cancer, and 246 patients with breast cancer to be treated with curative R(CH)T at the University Hospital Carl Gustav Carus Dresden, Germany will be included in this investigation. Dosimetric parameters from the applied radiation treatment plans, magnetic-resonance-imaging, electrocardiography, transthoracic echocardiography as well as blood-biomarkers will be collected to determine their predictive power against the primary endpoint of cumulative grade ≥ 2 cardio-toxicity (Common Terminology Criteria for Adverse Events [CTCAE] v 5.0) 3-5 years after R(CH)T.
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
- •Patients 18 years old or older
- •Patient's consent and written consent is available
- •Patients with the non-small cell lung cancer or esophageal cancer or breast cancer who have an indication for intended curative radio(chemo)therapy (in the case of breast cancer inclusion of female patients only)
排除标准
- •Patients who are not capable of giving consent
- •Pregnant women
- •Patients with contraindications for MRI examinations (pacemakers, defibrillators, neurostimulators, aneurysm clips, cochlear implants, permanent make-up, metal splinters or osseosynthetic implants)
- •Patients with insufficient kidney function (glomerular filtration rate (GFR) of less than 30 ml/min)
- •Patients with the aforementioned tumour entities for whom a palliative indication exists
结局指标
主要结局
Cumulative cardio-toxicity after 1 or 5 years
时间窗: 12 or 60 months after end of treatment
Cumulative grade ≥ 2 cardio-toxicity (Common Terminology Criteria for Adverse Events \[CTCAE\] v 5.0) 1 years after R(CH)T in patients with non-small cell lung or esophageal cancer or 5 years after R(CH)T in patients with breast cancer
次要结局
- Cumulative cardio-toxicity (early and late)(3 months as well as 2, 3, 4, 5 and 10 years after end of treatment)
研究者
Prof. Esther Troost
Prof. Dr. med. Dr.
Technische Universität Dresden