Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated with Chemoradiation Therapy
- Conditions
- Lung Cancer Stage IIILung Cancer Stage IICardiotoxicityRadiation Toxicity
- Interventions
- Other: Chemoradiation
- Registration Number
- NCT04305613
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 221
- 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
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort Chemoradiation Patients with locally advanced non-small cell lung cancer
- Primary Outcome Measures
Name Time Method Left Ventricular Strain up to 12 months Change in echo-derived measures of LV peak systolic strain (longitudinal) from baseline
Growth Differentiation Factor 15 up to 12 months Change in GDF-15 from baseline
Coronary Flow Reserve (CFR_ 6 months Change in PET/CT derived CFR from baseline
Ventricular Arterial Coupling up to 12 months Change in echo-derived measures of ventricular-arterial coupling (Ea/Ees) from baseline
Cardiovascular Specific Mortality (2 Year) 24 Months Cardiovascular specific mortality assessed by EMR review
Major Cardiovascular Events (2 Year) up to 24 months Incidence of MCE assessed by EMR review and patient interview
High Sensitivity C-Reactive Protein up to 12 months Change in hsCRP from baseline
Placental Growth Factor up to 12 months Change in PIGF from baseline
Overall Survival (2 Year) 24 months All-cause mortality assessed by electronic medical record (EMR) review
- Secondary Outcome Measures
Name Time Method FACIT Dyspnea Score up to 5 years Change in FACIT Dyspnea score from baseline. Score ranges from 0-30. Higher scores indicate more dyspnea.
Right Ventricular Fractional Area Change (RAC) up to 12 months Change in echo-derived RAC from baseline
High-Sensitivity Troponin T up to 12 months Change in hsTnT from baseline
N-type pro Brain Natriuretic Peptide up to 12 months Change in NTproBNP from baseline
Right Ventricular Longitudinal Strain up to 12 months Change in echo-derived RV longitudinal strain from baseline
Circumferential Strain up to 12 months Change in echo-derived circumferential strain from baseline
Left Ventricular Ejection Fraction (2D) up to 12 months Change in echo-derived LVEF from baseline
Global and Regional Myocardial Blood Flow at Rest up to 6 months Change in PET/CT derived measures of global and regional myocardial blood flow at rest from baseline
FACIT Fatigue Score up to 5 years Change in FACIT Fatigue score from baseline. Score ranges from 0-52. Higher scores indicated less fatigue.
Godin Leisure Time Exercise Score up to 5 years Change in Godin Leisure Time Exercise Score from baseline. Higher scores indicate higher levels of physical activity.
Diastolic Function up to 12 months Change in echo-derived measures of diastolic function from baseline
Left Ventricular Ejection Fraction (3D) up to 12 months Change in 3D echocardiography derived LVEF from baseline
Global and Regional Myocardial Blood Flow at Stress up to 6 months Change in PET/CT derived measures of global and regional myocardial blood flow at stress from baseline
Left Ventricular Twist and Torsion up to 12 months Change in 3D echocardiography derived measures of LV twist and torsion from baseline
Valvular Disease up to 12 months Change in echo-derived measures of valvular disease (degree of regurgitation or stenosis) from baseline
Left Ventricular systolic strain (3D) up to 12 months Change in 3D echocardiography derived measures of LV systolic strain from baseline
Trial Locations
- Locations (8)
Rutger's University / Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
The Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Chester County Hospital
🇺🇸West Chester, Pennsylvania, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States