Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry

Lung Neoplasm Clinical Trial

Official title:

Cardiovascular Morbidities and Lung Cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03368820
• Other study ID #: 01151
• Status: Recruiting
• Start date: December 4, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: European Lung Cancer Working Party
• Contact: Thierry Berghmans, MD, PhD
• Phone: 00322541311
• Email: thierry.berghmans[@]bordet.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Intervention

Other:
• No intervention
Treatment left at the discretion of the participant

Locations

Country	Name	City	State
Belgium	Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Brussels
Belgium	Hôpital Saint-Joseph	Charleroi
Belgium	CHU Tivoli	La Louvière
Belgium	Hôpital Ambroise Paré	Mons
Belgium	CH Peltzer-La Tourelle	Verviers
Belgium	Hôpital Mont-Godinne	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
European Lung Cancer Working Party

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment decision adequacy	Comparison of physician's treatment decision to current ELCWP guidelines	1 year
Secondary	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
Secondary	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)
Secondary	Overall survival	Survival will be measured from the day of diagnostic biopsy. All patients have to be followed until death	1 year