Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry

Cardiovascular Morbidities and Lung Cancer Treatment

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

Study Overview

• Status: Recruiting
• Conditions: Lung Neoplasm
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Thierry Berghmans, MD, PhD; Phone Number: 3192 00322541311; Email: thierry.berghmans@bordet.be
• Study Contact Backup: Name: Anne-Pascale Meert, MD, PhD; Phone Number: 3192 003225413111; Email: nathalie.leclercq@bordet.be

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Recruiting
    • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
    • Contact: Thierry Berghmans, MD; Phone Number: 0032/2/5390496
    • Principal Investigator: Thierry Berghmans, MD
  • Charleroi, Belgium
    • Recruiting
    • Hôpital Saint-Joseph
  • La Louvière, Belgium
    • Recruiting
    • CHU Tivoli
    • Contact: Ingrid CsToth, MD
    • Principal Investigator: Ingrid CsToth, MD
  • Mons, Belgium
    • Recruiting
    • Hôpital Ambroise Paré
  • Verviers, Belgium, 4800
    • Recruiting
    • CH Peltzer-La Tourelle
    • Contact: Yves Bonduelle, MD
    • Principal Investigator: Yves Bonduelle, MD
  • Yvoir, Belgium, 5530
    • Recruiting
    • Hôpital Mont-Godinne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any untreated lung cancer whatever the treatment intent

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: European Lung Cancer Working Party

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: lung neoplasms; cardiovascular co-morbidity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 01151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No