Lung Cancer Clinical Trial

Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy

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.

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Full 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.

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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).

Study is for people with:

Lung Cancer

Estimated Enrollment:

221

Study ID:

NCT04305613

Recruitment Status:

Enrolling by invitation

Sponsor:

Abramson Cancer Center at Penn Medicine

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There are 7 Locations for this study

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University of Alabama
Birmingham Alabama, 35233, United States
The Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Rutger's University / Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Montefiore Medical Center
Bronx New York, 19046, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Chester County Hospital
West Chester Pennsylvania, 19380, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

221

Study ID:

NCT04305613

Recruitment Status:

Enrolling by invitation

Sponsor:


Abramson Cancer Center at Penn Medicine

How clear is this clinincal trial information?

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