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.
Brief Title
Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated with Chemoradiation Therapy
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Cardiotoxicity
Lung Cancer Stage III
Lung Cancer Stage II
Radiation Toxicity
Eligibility Criteria
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).
* 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).
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Radiation Therapy Cardiotoxicity
Cardiovascular Risk Factors
Lung Cancer
Cardiovascular Phenotyping
Radiation Therapy
Cardiovascular Disease
Cardio-Oncology
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04305613
Org Class
Other
Org Full Name
Abramson Cancer Center at Penn Medicine
Org Study Id
UPCC 13519
Overall Status
Enrolling by invitation
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated with Chemoradiation Therapy: a Prospective Longitudinal Cohort
Primary Outcomes
Outcome Description
Change in hsCRP from baseline
Outcome Measure
High Sensitivity C-Reactive Protein
Outcome Time Frame
up to 12 months
Outcome Description
Change in GDF-15 from baseline
Outcome Measure
Growth Differentiation Factor 15
Outcome Time Frame
up to 12 months
Outcome Description
Change in PIGF from baseline
Outcome Measure
Placental Growth Factor
Outcome Time Frame
up to 12 months
Outcome Description
Change in echo-derived measures of LV peak systolic strain (longitudinal) from baseline
Outcome Measure
Left Ventricular Strain
Outcome Time Frame
up to 12 months
Outcome Description
Change in echo-derived measures of ventricular-arterial coupling (Ea/Ees) from baseline
Outcome Measure
Ventricular Arterial Coupling
Outcome Time Frame
up to 12 months
Outcome Description
Change in PET/CT derived CFR from baseline
Outcome Measure
Coronary Flow Reserve (CFR_
Outcome Time Frame
6 months
Outcome Description
All-cause mortality assessed by electronic medical record (EMR) review
Outcome Measure
Overall Survival (2 Year)
Outcome Time Frame
24 months
Outcome Description
Cardiovascular specific mortality assessed by EMR review
Outcome Measure
Cardiovascular Specific Mortality (2 Year)
Outcome Time Frame
24 Months
Outcome Description
Incidence of MCE assessed by EMR review and patient interview
Outcome Measure
Major Cardiovascular Events (2 Year)
Outcome Time Frame
up to 24 months
Secondary Outcomes
Outcome Description
Change in hsTnT from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
High-Sensitivity Troponin T
Outcome Description
Change in NTproBNP from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
N-type pro Brain Natriuretic Peptide
Outcome Description
Change in echo-derived LVEF from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
Left Ventricular Ejection Fraction (2D)
Outcome Description
Change in echo-derived RAC from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
Right Ventricular Fractional Area Change (RAC)
Outcome Description
Change in echo-derived RV longitudinal strain from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
Right Ventricular Longitudinal Strain
Outcome Description
Change in echo-derived circumferential strain from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
Circumferential Strain
Outcome Description
Change in echo-derived measures of diastolic function from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
Diastolic Function
Outcome Description
Change in echo-derived measures of valvular disease (degree of regurgitation or stenosis) from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
Valvular Disease
Outcome Description
Change in 3D echocardiography derived LVEF from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
Left Ventricular Ejection Fraction (3D)
Outcome Description
Change in 3D echocardiography derived measures of LV systolic strain from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
Left Ventricular systolic strain (3D)
Outcome Description
Change in 3D echocardiography derived measures of LV twist and torsion from baseline
Outcome Time Frame
up to 12 months
Outcome Measure
Left Ventricular Twist and Torsion
Outcome Description
Change in PET/CT derived measures of global and regional myocardial blood flow at rest from baseline
Outcome Time Frame
up to 6 months
Outcome Measure
Global and Regional Myocardial Blood Flow at Rest
Outcome Description
Change in PET/CT derived measures of global and regional myocardial blood flow at stress from baseline
Outcome Time Frame
up to 6 months
Outcome Measure
Global and Regional Myocardial Blood Flow at Stress
Outcome Description
Change in FACIT Fatigue score from baseline. Score ranges from 0-52. Higher scores indicated less fatigue.
Outcome Time Frame
up to 5 years
Outcome Measure
FACIT Fatigue Score
Outcome Description
Change in FACIT Dyspnea score from baseline. Score ranges from 0-30. Higher scores indicate more dyspnea.
Outcome Time Frame
up to 5 years
Outcome Measure
FACIT Dyspnea Score
Outcome Description
Change in Godin Leisure Time Exercise Score from baseline. Higher scores indicate higher levels of physical activity.
Outcome Time Frame
up to 5 years
Outcome Measure
Godin Leisure Time Exercise Score
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients with lung cancer will be enrolled from the radiation oncology clinics at participating sites.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nitin Ohri
Investigator Email
nitin.ohri@einsteinmed.edu
Investigator Phone
516-672-2711