Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry

Study Overview
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Brief Summary
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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

Official Title
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Cardiovascular Morbidities and Lung Cancer Treatment

Conditions
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Lung Neoplasm

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|Treatment left at the discretion of the participant|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment decision adequacy | Comparison of physician's treatment decision to current ELCWP guidelines | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment decision adequacy according to histology | Comparison of physician's treatment decision to current ELCWP guidelines separately in small (SCLC) and non-small lung cancer (NSCLC) | 1 year | 
| Response rate | Response rate in patients with cardiovascular co-morbidities and adapted treatment using (World Health Organisation (WHO) criteria | Every 3 cycles for chemotherapy (9 weeks) or 1 month after completion of radiochemotherapy (15 weeks) | 
| Overall survival | Survival will be measured from the day of diagnostic biopsy. All patients have to be followed until death | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung neoplasms, cardiovascular co-morbidity