Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04305613

Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy

This observational cohort will evaluate the cardiovascular effects of chemoradiation used to treat locally advanced, non-small cell lung cancer. Patients will be enrolled prior to the start of therapy and followed during and for at least 2 years after therapy with echocardiograms, nuclear stress tests, blood sampling, and quality of life surveys.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Lung Cancer Stage II Lung Cancer Stage III Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Radiation Toxicity Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

About this study

Lung cancer is both the most common malignancy worldwide and the leading cause of cancer death in the US. While radiation therapy is highly effective for many solid tumors, thoracic radiation therapy carries a risk of cardiovascular morbidity and mortality that limits critical gains in cancer control and survival. The investigators will perform detailed cardiovascular phenotyping using biologic and imaging markers to define functional and physiologic perturbations that occur with radiation therapy. The study will provide insights into how cardiovascular risk factors and disease impact these biologic and functional changes. The investigators will also determine which radiotherapy dose-volume metrics are indicative of subclinical cardiotoxicity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • Histologically confirmed or clinically diagnosed non-small cell lung cancer where the plan is for definitive treatment that includes radiation
  • Able to give written informed consent

Exclusion criteria

  • Pregnant or breast-feeding
  • Prior treatment with anthracyclines
  • Radiation treatment not expected to involve any heart exposure as determined by treating provider
  • ECOG performance status greater than 2
  • Vulnerable patients, including pregnant women and prisoners
  • Contraindication to rest/vasodilator stress PET/CT, including: asthma with ongoing wheezing at time of enrollment; known Mobitz Type II AV block, 3rd degree AV block, or sick sinus syndrom, without a pacemaker; systolic blood pressure less than 90mmHg; known hypersensitivity to Regadenoson and adenosine; profound sinus bradycardia (heart rate less than 40bpm).

Treatment and study plan

Chemoradiation

Other

Patients will be treated with definitive concurrent chemoradiation with curative intent as determined by their medical and radiation oncologists. We will consider timing of initiation and discontinuation, type, and cumulative dose of platinum based chemotherapy. We will also consider dose, duration, and type of immunotherapy. Radiation therapy will be delivered via proton or proton therapy. Our primary radiation therapy dose-volume exposures are whole heart volumetric dose. As secondary exposures, we will comprehensively define radiation therapy dose parameters to the right ventricle, entire left ventricle, left ventricle segments, coronary arteries, and mean heart dose.

Primary outcomes

  1. High Sensitivity C-Reactive Protein

    Time frame: up to 12 months

    Change in hsCRP from baseline

  2. Growth Differentiation Factor 15

    Time frame: up to 12 months

    Change in GDF-15 from baseline

  3. Placental Growth Factor

    Time frame: up to 12 months

    Change in PIGF from baseline

  4. Left Ventricular Strain

    Time frame: up to 12 months

    Change in echo-derived measures of LV peak systolic strain (longitudinal) from baseline

  5. Ventricular Arterial Coupling

    Time frame: up to 12 months

    Change in echo-derived measures of ventricular-arterial coupling (Ea/Ees) from baseline

  6. Coronary Flow Reserve (CFR_

    Time frame: 6 months

    Change in PET/CT derived CFR from baseline

  7. Overall Survival (2 Year)

    Time frame: 24 months

    All-cause mortality assessed by electronic medical record (EMR) review

  8. Cardiovascular Specific Mortality (2 Year)

    Time frame: 24 Months

    Cardiovascular specific mortality assessed by EMR review

  9. Major Cardiovascular Events (2 Year)

    Time frame: up to 24 months

    Incidence of MCE assessed by EMR review and patient interview

Secondary outcomes

  1. High-Sensitivity Troponin T

    Time frame: up to 12 months

    Change in hsTnT from baseline

  2. N-type pro Brain Natriuretic Peptide

    Time frame: up to 12 months

    Change in NTproBNP from baseline

  3. Left Ventricular Ejection Fraction (2D)

    Time frame: up to 12 months

    Change in echo-derived LVEF from baseline

  4. Right Ventricular Fractional Area Change (RAC)

    Time frame: up to 12 months

    Change in echo-derived RAC from baseline

  5. Right Ventricular Longitudinal Strain

    Time frame: up to 12 months

    Change in echo-derived RV longitudinal strain from baseline

  6. Circumferential Strain

    Time frame: up to 12 months

    Change in echo-derived circumferential strain from baseline

  7. Diastolic Function

    Time frame: up to 12 months

    Change in echo-derived measures of diastolic function from baseline

  8. Valvular Disease

    Time frame: up to 12 months

    Change in echo-derived measures of valvular disease (degree of regurgitation or stenosis) from baseline

  9. Left Ventricular Ejection Fraction (3D)

    Time frame: up to 12 months

    Change in 3D echocardiography derived LVEF from baseline

  10. Left Ventricular systolic strain (3D)

    Time frame: up to 12 months

    Change in 3D echocardiography derived measures of LV systolic strain from baseline

  11. Left Ventricular Twist and Torsion

    Time frame: up to 12 months

    Change in 3D echocardiography derived measures of LV twist and torsion from baseline

  12. Global and Regional Myocardial Blood Flow at Rest

    Time frame: up to 6 months

    Change in PET/CT derived measures of global and regional myocardial blood flow at rest from baseline

  13. Global and Regional Myocardial Blood Flow at Stress

    Time frame: up to 6 months

    Change in PET/CT derived measures of global and regional myocardial blood flow at stress from baseline

  14. FACIT Fatigue Score

    Time frame: up to 5 years

    Change in FACIT Fatigue score from baseline. Score ranges from 0-52. Higher scores indicated less fatigue.

  15. FACIT Dyspnea Score

    Time frame: up to 5 years

    Change in FACIT Dyspnea score from baseline. Score ranges from 0-30. Higher scores indicate more dyspnea.

  16. Godin Leisure Time Exercise Score

    Time frame: up to 5 years

    Change in Godin Leisure Time Exercise Score from baseline. Higher scores indicate higher levels of physical activity.

Other outcomes

  1. Overall Survival (5 Year)

    Time frame: 5-8 years

    All Cause Mortality assessed by National Death Index Search performed 5 years after the last patient is enrolled.

  2. Cardiovascular Specific Mortality (5 Year)

    Time frame: 5-8 Years

    Cardiovascular Specific Mortality by National Death Index Search performed approximately 5 years after the final patient is enrolled.

  3. Major Cardiovascular Events (5 Year)

    Time frame: 5 years

    Incidence of 5-Year MCE by EMR review and patient interview

  4. NCI Patient Reported Outcomes Common Terms and Criteria for Adverse Events (PRO-CTCAE)

    Time frame: 5 Years

    Incidence of symptomatic adverse events as assessed by NCI's PRO-CTCAE

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy: A Prospective Longitudinal Cohort

Acronym: CLARITY

Important dates

Study start
2020
Primary completion
2026
Study completion
2030
First posted
Mar 12, 2020
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.