Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry

• Conditions: Lung Neoplasm

• Registration Number: NCT03368820
• Lead Sponsor: European Lung Cancer Working Party

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-24
• Study Start: 2017-12-04
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment decision adequacy	1 year	Comparison of physician's treatment decision to current ELCWP guidelines

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Hôpital Saint-Joseph; 🇧🇪 Charleroi, Belgium

CHU Tivoli; 🇧🇪 La Louvière, Belgium

CH Peltzer-La Tourelle; 🇧🇪 Verviers, Belgium

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Hôpital Ambroise Paré; 🇧🇪 Mons, Belgium

Hôpital Mont-Godinne; 🇧🇪 Yvoir, Belgium