CardiotoxicityCLARITYNCT04305613
Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy
An observational study of Cardiotoxicity and Lung Cancer Stage III, run by Abramson Cancer Center at Penn Medicine at 8 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity, Lung Cancer Stage III, Lung Cancer Stage II
- What is being tested?
- Chemoradiation
- How many people
- 221 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Sep 2020to Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lung cancer will be enrolled from the radiation oncology clinics at participating sites.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama
Birmingham, Alabama, 35233
The Brigham and Women's Hospital
Boston, Massachusetts, 02115
Lancaster General Hospital
Lancaster, Pennsylvania, 17601
Rutger's University / Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 190467
Chester County Hospital
West Chester, Pennsylvania, 19380
About this study
Official title: Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy: A Prospective Longitudinal Cohort
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.
Read the 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.
- Being tested
- Chemoradiation
- Keywords
- Radiation Therapy Cardiotoxicity, Cardiovascular Risk Factors, Lung Cancer, Cardiovascular Phenotyping, Radiation Therapy, Cardiovascular Disease, Cardio-Oncology
- Medical subject headings
- Cardiotoxicity, Lung Neoplasms, Radiation Injuries, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients with locally advanced non-small cell lung cancer Receives: Other: Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Sensitivity C-Reactive Protein
Change in hsCRP from baseline
Measured: up to 12 months
Growth Differentiation Factor 15
Change in GDF-15 from baseline
Measured: up to 12 months
Placental Growth Factor
Change in PIGF from baseline
Measured: up to 12 months
Left Ventricular Strain
Change in echo-derived measures of LV peak systolic strain (longitudinal) from baseline
Measured: up to 12 months
Ventricular Arterial Coupling
Change in echo-derived measures of ventricular-arterial coupling (Ea/Ees) from baseline
Measured: up to 12 months
Coronary Flow Reserve (CFR_
Change in PET/CT derived CFR from baseline
Measured: 6 months
Overall Survival (2 Year)
All-cause mortality assessed by electronic medical record (EMR) review
Measured: 24 months
Cardiovascular Specific Mortality (2 Year)
Cardiovascular specific mortality assessed by EMR review
Measured: 24 Months
Major Cardiovascular Events (2 Year)
Incidence of MCE assessed by EMR review and patient interview
Measured: up to 24 months
Secondary outcomes (16)
High-Sensitivity Troponin T
Change in hsTnT from baseline
Measured: up to 12 months
N-type pro Brain Natriuretic Peptide
Change in NTproBNP from baseline
Measured: up to 12 months
Left Ventricular Ejection Fraction (2D)
Change in echo-derived LVEF from baseline
Measured: up to 12 months
Right Ventricular Fractional Area Change (RAC)
Change in echo-derived RAC from baseline
Measured: up to 12 months
Right Ventricular Longitudinal Strain
Change in echo-derived RV longitudinal strain from baseline
Measured: up to 12 months
Circumferential Strain
Change in echo-derived circumferential strain from baseline
Measured: up to 12 months
Diastolic Function
Change in echo-derived measures of diastolic function from baseline
Measured: up to 12 months
Valvular Disease
Change in echo-derived measures of valvular disease (degree of regurgitation or stenosis) from baseline
Measured: up to 12 months
Left Ventricular Ejection Fraction (3D)
Change in 3D echocardiography derived LVEF from baseline
Measured: up to 12 months
Left Ventricular systolic strain (3D)
Change in 3D echocardiography derived measures of LV systolic strain from baseline
Measured: up to 12 months
Left Ventricular Twist and Torsion
Change in 3D echocardiography derived measures of LV twist and torsion from baseline
Measured: up to 12 months
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
Measured: up to 6 months
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
Measured: up to 6 months
FACIT Fatigue Score
Change in FACIT Fatigue score from baseline. Score ranges from 0-52. Higher scores indicated less fatigue.
Measured: up to 5 years
FACIT Dyspnea Score
Change in FACIT Dyspnea score from baseline. Score ranges from 0-30. Higher scores indicate more dyspnea.
Measured: up to 5 years
Godin Leisure Time Exercise Score
Change in Godin Leisure Time Exercise Score from baseline. Higher scores indicate higher levels of physical activity.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start14 Sep 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bonnie Ky, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305613
- Sponsor's protocol ID
- UPCC 13519
- Acronym
- CLARITY
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2020
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participants may opt in to allowing data and/or banked samples to be used for future research and shared with other researchers. A detailed plan for sharing IPD will be finalized at a later date, and may depend in part on how many participants elect this option. Additional supporting information may be shared, including the study protocol and informed consent form.