Radiation Toxicity Clinical Trial
— CLARITYOfficial title:
Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy: A Prospective Longitudinal Cohort
Verified date | June 2024 |
Source | Abramson Cancer Center at Penn Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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). |
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 |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center at Penn Medicine |
United States,
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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