Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy (CLARITY)

September 29, 2025 updated by: Abramson Cancer Center at Penn Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • The Brigham and Women's Hospital
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutger's University / Cancer Institute of New Jersey
    • New York
      • The Bronx, New York, United States, 190467
        • Montefiore Medical Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania
      • West Chester, Pennsylvania, United States, 19380
        • Chester County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with lung cancer will be enrolled from the radiation oncology clinics at participating sites.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort
Patients with locally advanced non-small cell lung cancer
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
High Sensitivity C-Reactive Protein
Time Frame: up to 12 months
Change in hsCRP from baseline
up to 12 months
Growth Differentiation Factor 15
Time Frame: up to 12 months
Change in GDF-15 from baseline
up to 12 months
Placental Growth Factor
Time Frame: up to 12 months
Change in PIGF from baseline
up to 12 months
Left Ventricular Strain
Time Frame: up to 12 months
Change in echo-derived measures of LV peak systolic strain (longitudinal) from baseline
up to 12 months
Ventricular Arterial Coupling
Time Frame: up to 12 months
Change in echo-derived measures of ventricular-arterial coupling (Ea/Ees) from baseline
up to 12 months
Coronary Flow Reserve (CFR_
Time Frame: 6 months
Change in PET/CT derived CFR from baseline
6 months
Overall Survival (2 Year)
Time Frame: 24 months
All-cause mortality assessed by electronic medical record (EMR) review
24 months
Cardiovascular Specific Mortality (2 Year)
Time Frame: 24 Months
Cardiovascular specific mortality assessed by EMR review
24 Months
Major Cardiovascular Events (2 Year)
Time Frame: up to 24 months
Incidence of MCE assessed by EMR review and patient interview
up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
High-Sensitivity Troponin T
Time Frame: up to 12 months
Change in hsTnT from baseline
up to 12 months
N-type pro Brain Natriuretic Peptide
Time Frame: up to 12 months
Change in NTproBNP from baseline
up to 12 months
Left Ventricular Ejection Fraction (2D)
Time Frame: up to 12 months
Change in echo-derived LVEF from baseline
up to 12 months
Right Ventricular Fractional Area Change (RAC)
Time Frame: up to 12 months
Change in echo-derived RAC from baseline
up to 12 months
Right Ventricular Longitudinal Strain
Time Frame: up to 12 months
Change in echo-derived RV longitudinal strain from baseline
up to 12 months
Circumferential Strain
Time Frame: up to 12 months
Change in echo-derived circumferential strain from baseline
up to 12 months
Diastolic Function
Time Frame: up to 12 months
Change in echo-derived measures of diastolic function from baseline
up to 12 months
Valvular Disease
Time Frame: up to 12 months
Change in echo-derived measures of valvular disease (degree of regurgitation or stenosis) from baseline
up to 12 months
Left Ventricular Ejection Fraction (3D)
Time Frame: up to 12 months
Change in 3D echocardiography derived LVEF from baseline
up to 12 months
Left Ventricular systolic strain (3D)
Time Frame: up to 12 months
Change in 3D echocardiography derived measures of LV systolic strain from baseline
up to 12 months
Left Ventricular Twist and Torsion
Time Frame: up to 12 months
Change in 3D echocardiography derived measures of LV twist and torsion from baseline
up to 12 months
Global and Regional Myocardial Blood Flow at Rest
Time Frame: up to 6 months
Change in PET/CT derived measures of global and regional myocardial blood flow at rest from baseline
up to 6 months
Global and Regional Myocardial Blood Flow at Stress
Time Frame: up to 6 months
Change in PET/CT derived measures of global and regional myocardial blood flow at stress from baseline
up to 6 months
FACIT Fatigue Score
Time Frame: up to 5 years
Change in FACIT Fatigue score from baseline. Score ranges from 0-52. Higher scores indicated less fatigue.
up to 5 years
FACIT Dyspnea Score
Time Frame: up to 5 years
Change in FACIT Dyspnea score from baseline. Score ranges from 0-30. Higher scores indicate more dyspnea.
up to 5 years
Godin Leisure Time Exercise Score
Time Frame: up to 5 years
Change in Godin Leisure Time Exercise Score from baseline. Higher scores indicate higher levels of physical activity.
up to 5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (5 Year)
Time Frame: 5-8 years
All Cause Mortality assessed by National Death Index Search performed 5 years after the last patient is enrolled.
5-8 years
Cardiovascular Specific Mortality (5 Year)
Time Frame: 5-8 Years
Cardiovascular Specific Mortality by National Death Index Search performed approximately 5 years after the final patient is enrolled.
5-8 Years
Major Cardiovascular Events (5 Year)
Time Frame: 5 years
Incidence of 5-Year MCE by EMR review and patient interview
5 years
NCI Patient Reported Outcomes Common Terms and Criteria for Adverse Events (PRO-CTCAE)
Time Frame: 5 Years
Incidence of symptomatic adverse events as assessed by NCI's PRO-CTCAE
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abramson Cancer Center at Penn Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bonnie Ky, MD, MSCE, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPCC 13519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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