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

Abramson Cancer Center at Penn Medicine

Status: Invitation-only

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

Treatments: Other: Chemoradiation

Study type: Observational

Funder types: Other

Identifiers

NCT04305613

UPCC 13519

Details and patient eligibility

About

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.

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.

Enrollment: 221 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

221 participants in 1 patient group

Cohort

Description:

Patients with locally advanced non-small cell lung cancer

Treatment:

Other: Chemoradiation