NCT03368820Unknown不适用
Cardiovascular Morbidities and Lung Cancer Treatment
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Treatment decision adequacy
研究概览
简要总结
Therapeutic algorithms for lung cancer are mainly based on randomised controlled trials which excluded patients with severe co-morbidities. Smoking, the main risk factor for lung cancer, is associated with cardiovascular events that may impact on the therapeutic decision.
The aim of this registry is to determine if and how cardiovascular co-morbidities impact on the physicians' decision for anticancer treatment in lung cancer patients by comparing it to the European Lung Cancer Working Party (ELCWP) guidelines
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
- •Histological diagnosis of lung cancer, either NSCLC or SCLC patients and carcinoid tumours
- •Untreated lung cancer of any stage and any treatment (including palliative care only).
- •Availability for participating in the detailed follow-up of the protocol.
- •Signed informed consent.
- •Age above 18 years.
- •Presence of at least one co-morbidity:
- •Any active or past cardiac ischemia
- •Reduced left ventricular ejection fraction (< 50%)
- •Obstructive cardiomyopathy
- •Valvular dysfunction (3 or 4/4; valvular replacement)
- •Arrhythmia (atrial flutter or fibrillation, significant ventricular arrhythmia, 2nd-3rd degree auriculo-ventricular block, Wolf-Parkinson-White and other similar aberrant conduction, bifascicular block, arrhythmogenic right ventricular dysplasia)
- •Uncontrolled hypertension (systolic blood pressure (BP) > 160 millimeter of mercury (mmHg) or diastolic BP > 100 mmHg on ≥ 1 hypotensive drug) or controlled hypertension on ≥ 2 concurrent hypotensive drugs
- •Active or treated peripheral arteritis (grade 2 or more)
- •Cerebrovascular events
- •Pulmonary embolism and/or thrombophlebitis or patients at high risk of thrombophilia (homozygous Leiden factor...)
- •Aortic aneurism
排除标准
- •Thymoma and thymic malignancies, pleural mesothelioma.
- •Patient previously treated for lung cancer.
- •Tumours for which complete staging cannot be assessed.
- •History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval).
结局指标
主要结局
Treatment decision adequacy
时间窗: 1 year
Comparison of physician's treatment decision to current ELCWP guidelines
次要结局
- Overall survival(1 year)
- Response rate(Every 3 cycles for chemotherapy (9 weeks) or 1 month after completion of radiochemotherapy (15 weeks))
- Treatment decision adequacy according to histology(1 year)
研究者
研究点 (6)
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