Radiation-induced Cardiac Toxicity After Non-small Cell Lung Cancer Radiotherapy

NCT04867564 | Unknown

• 1 other identifier: 20/WIM/2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the growing interest in investigating how the radiotherapy (RT) dose to anatomical substructures of the heart links to survival, the heart substructures at risk remain poorly defined. They are not delineated routinely as part of the RT planning process and there is no consensus on their dose constrains. With improving prognosis for non-small cell lung cancer (NSCLC) patients, the evidence relating irradiation of the heart to excess mortality has begun to accumulate. The study aims to evaluate subclinical cardiac dysfunction in consecutive NSCLC patients treated with definitive RT and to investigate the predictive value of the heart substructures dosimetric parameters for subclinical and overt cardiac toxicity as assessed using traditional and speckle tracking echocardiography (STE). The study will also investigate whether subclinical alterations detected by echocardiography with strain imaging may serve as a marker for future clinical dysfunctions.

Conditions

Non-small Cell Lung Cancer; Radiation Toxicity; Cardiac Toxicity

Outcome Measures

Primary Outcomes (1)

• RT-induced systolic and diastolic function alterations

  Systolic and diastolic function alterations assessed using traditional echocardiographic parameters as well as speckle tracking echocardiography analysis at 1, 6, and 12 months after RT compared to baseline.

  1 year

Secondary Outcomes (3)

• The predictive value of cardiac substructures dosimetric parameters for cardiac toxicity as evaluated using STE and traditional echocardiographic parameters

  1 year

• The predictive value of subclinical alterations detected by echocardiography for future clinical dysfunctions

  1 year

• Cumulative incidence of cardiac disorders, as classified by CTCAE4.0

  1 year

Study Arms (1)

NSCLC patients treated with curative radiotherapy

Consecutive NSCLC patients treated with standard RT with curative intent with or without platinum-based CHT

Diagnostic Test: Echocardiography

Interventions

Echocardiography DIAGNOSTIC_TEST

Traditional echocardiography and speckle tracking echocardiography (STE) before and 1, 6, and 12 months after RT

NSCLC patients treated with curative radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be included in one institution (Military Institute of Medicine, Warsaw, Poland). Accrual of 50 patients a year is anticipated, the planned accrual period is two years.

You may qualify if:

• Age 18 or older
• Ability to provide informed consent
• Histologically confirmed non-small cell carcinoma of the lung
• Patient to receive standard RT with curative intent with or without concurrent or sequential CHT according to the institutional protocol
• ECOG performance status 0-1 within one month of accrual
• Negative pregnancy test within one month of accrual if woman is premenopausal
• Patient presented at multidisciplinary tumor board or quality-assurance rounds
• Satisfactory pulmonary function tests, i.e., forced expiratory volume during the first second (FEV1) ≥ 1.0 l (≥40%)

You may not qualify if:

• Pregnancy
• Prior RT to the thorax
• Patient to receive stereotactic body radiation therapy (SBRT)

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Department of Radiotherapy, Military Institute of Medicine

Warsaw, Masovian Voivodeship, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Radiation Injuries; Cardiotoxicity

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Joanna Socha, MD, PhD

  Military Institute od Medicine National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna Socha, MD, PhD

CONTACT

888302360; jsocha@wim.mil.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

PL (1)