Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy

NCT04305613 | Active Not Recruiting

• 1 other identifier: UPCC 13519
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 8

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.

Conditions

Cardiotoxicity; Lung Cancer Stage III; Lung Cancer Stage II; Radiation Toxicity

Keywords

Radiation Therapy Cardiotoxicity; Cardiovascular Risk Factors; Lung Cancer; Cardiovascular Phenotyping; Radiation Therapy; Cardiovascular Disease; Cardio-Oncology

Outcome Measures

Primary Outcomes (9)

• High Sensitivity C-Reactive Protein

  Change in hsCRP from baseline

  up to 12 months

• Growth Differentiation Factor 15

  Change in GDF-15 from baseline

  up to 12 months

• Placental Growth Factor

  Change in PIGF from baseline

  up to 12 months

• Left Ventricular Strain

  Change in echo-derived measures of LV peak systolic strain (longitudinal) from baseline

  up to 12 months

• Ventricular Arterial Coupling

  Change in echo-derived measures of ventricular-arterial coupling (Ea/Ees) from baseline

  up to 12 months

• Coronary Flow Reserve (CFR_

  Change in PET/CT derived CFR from baseline

  6 months

• Overall Survival (2 Year)

  All-cause mortality assessed by electronic medical record (EMR) review

  24 months

• Cardiovascular Specific Mortality (2 Year)

  Cardiovascular specific mortality assessed by EMR review

  24 Months

• Major Cardiovascular Events (2 Year)

  Incidence of MCE assessed by EMR review and patient interview

  up to 24 months

Secondary Outcomes (16)

• High-Sensitivity Troponin T

  up to 12 months

• N-type pro Brain Natriuretic Peptide

  up to 12 months

• Left Ventricular Ejection Fraction (2D)

  up to 12 months

• Right Ventricular Fractional Area Change (RAC)

  up to 12 months

• Right Ventricular Longitudinal Strain

  up to 12 months

Other Outcomes (4)

• Overall Survival (5 Year)

  5-8 years

• Cardiovascular Specific Mortality (5 Year)

  5-8 Years

• Major Cardiovascular Events (5 Year)

  5 years

Study Arms (1)

Cohort

Patients with locally advanced non-small cell lung cancer

Other: Chemoradiation

Interventions

Chemoradiation OTHER

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.

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (8)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

The Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Rutger's University / Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Montefiore Medical Center

The Bronx, New York, 190467, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17601, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, and Buffy coat will be collected for planned biomarker analysis. Patients may optionally consent to have remaining blood banked for future analysis.

MeSH Terms

Conditions

Cardiotoxicity; Lung Neoplasms; Radiation Injuries; Cardiovascular Diseases

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Wounds and Injuries; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Bonnie Ky, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 12, 2020
• Study Start: September 14, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (8)