Clinical Trials Study
N/A
Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy
Conditions: Cardiotoxicity, Lung Cancer Stage III, Lung Cancer Stage II, Radiation Toxicity
- Study #:
- NCT04305613
- Last Updated:
- 10/02/2025
- Recruitment Status:
- Active, not recruiting
- Estimated Study Completion Date:
- 12/01/2030
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.
Age: 18 Years and older
Gender: All
Start Date: 09/14/2020
Primary Completion Date (Estimated): 09/01/2026
Study Completion Date (Estimated): 12/01/2030
Accepts Healthy Volunteers: No
Trial Purpose and 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.
Eligibility Criteria
Age: 18 Years and older
Gender: All
Accepts Healthy Volunteers: No
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).
Principal Investigator
Nitin Ohri, MD, MS