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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04305613
Other study ID # UPCC 13519
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 14, 2020
Est. completion date December 2028

Study information

Verified date June 2024
Source Abramson Cancer Center at Penn Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Enrolling by invitation
Enrollment 221
Est. completion date December 2028
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

Other:
Chemoradiation
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.

Locations

Country Name City State
United States University of Alabama Birmingham Alabama
United States The Brigham and Women's Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Rutger's University / Cancer Institute of New Jersey New Brunswick New Jersey
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

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Overall Survival (5 Year) All Cause Mortality assessed by National Death Index Search performed 5 years after the last patient is enrolled. 5-8 years
Other Cardiovascular Specific Mortality (5 Year) Cardiovascular Specific Mortality by National Death Index Search performed approximately 5 years after the final patient is enrolled. 5-8 Years
Other Major Cardiovascular Events (5 Year) Incidence of 5-Year MCE by EMR review and patient interview 5 years
Other NCI Patient Reported Outcomes Common Terms and Criteria for Adverse Events (PRO-CTCAE) Incidence of symptomatic adverse events as assessed by NCI's PRO-CTCAE 5 Years
Primary High Sensitivity C-Reactive Protein Change in hsCRP from baseline up to 12 months
Primary Growth Differentiation Factor 15 Change in GDF-15 from baseline up to 12 months
Primary Placental Growth Factor Change in PIGF from baseline up to 12 months
Primary Left Ventricular Strain Change in echo-derived measures of LV peak systolic strain (longitudinal) from baseline up to 12 months
Primary Ventricular Arterial Coupling Change in echo-derived measures of ventricular-arterial coupling (Ea/Ees) from baseline up to 12 months
Primary Coronary Flow Reserve (CFR_ Change in PET/CT derived CFR from baseline 6 months
Primary Overall Survival (2 Year) All-cause mortality assessed by electronic medical record (EMR) review 24 months
Primary Cardiovascular Specific Mortality (2 Year) Cardiovascular specific mortality assessed by EMR review 24 Months
Primary Major Cardiovascular Events (2 Year) Incidence of MCE assessed by EMR review and patient interview up to 24 months
Secondary High-Sensitivity Troponin T Change in hsTnT from baseline up to 12 months
Secondary N-type pro Brain Natriuretic Peptide Change in NTproBNP from baseline up to 12 months
Secondary Left Ventricular Ejection Fraction (2D) Change in echo-derived LVEF from baseline up to 12 months
Secondary Right Ventricular Fractional Area Change (RAC) Change in echo-derived RAC from baseline up to 12 months
Secondary Right Ventricular Longitudinal Strain Change in echo-derived RV longitudinal strain from baseline up to 12 months
Secondary Circumferential Strain Change in echo-derived circumferential strain from baseline up to 12 months
Secondary Diastolic Function Change in echo-derived measures of diastolic function from baseline up to 12 months
Secondary Valvular Disease Change in echo-derived measures of valvular disease (degree of regurgitation or stenosis) from baseline up to 12 months
Secondary Left Ventricular Ejection Fraction (3D) Change in 3D echocardiography derived LVEF from baseline up to 12 months
Secondary Left Ventricular systolic strain (3D) Change in 3D echocardiography derived measures of LV systolic strain from baseline up to 12 months
Secondary Left Ventricular Twist and Torsion Change in 3D echocardiography derived measures of LV twist and torsion from baseline up to 12 months
Secondary Global and Regional Myocardial Blood Flow at Rest Change in PET/CT derived measures of global and regional myocardial blood flow at rest from baseline up to 6 months
Secondary Global and Regional Myocardial Blood Flow at Stress Change in PET/CT derived measures of global and regional myocardial blood flow at stress from baseline up to 6 months
Secondary FACIT Fatigue Score Change in FACIT Fatigue score from baseline. Score ranges from 0-52. Higher scores indicated less fatigue. up to 5 years
Secondary FACIT Dyspnea Score Change in FACIT Dyspnea score from baseline. Score ranges from 0-30. Higher scores indicate more dyspnea. up to 5 years
Secondary Godin Leisure Time Exercise Score Change in Godin Leisure Time Exercise Score from baseline. Higher scores indicate higher levels of physical activity. up to 5 years
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