Clinical trial NCT03368820: Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry
Official title: Cardiovascular Morbidities and Lung Cancer Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasm
Keywords: lung neoplasms
cardiovascular co-morbidity
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any untreated lung cancer whatever the treatment intent

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


Eligibility criteria: 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).

Primary outcomes:
measure: Treatment decision adequacy
timeFrame: 1 year
Secondary outcomes:
measure: Treatment decision adequacy according to histology
timeFrame: 1 year
measure: Response rate
timeFrame: Every 3 cycles for chemotherapy (9 weeks) or 1 month after completion of radiochemotherapy (15 weeks)
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
city: Charleroi
country: Belgium
facility: Hôpital Saint-Joseph
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Mons
country: Belgium
facility: Hôpital Ambroise Paré
city: Verviers
country: Belgium
facility: CH Peltzer-La Tourelle
city: Yvoir
country: Belgium
facility: Hôpital Mont-Godinne
Study officials:
affiliation: ELCWP
name: Thierry Berghmans, MD, PhD
role: STUDY_CHAIR
References: