Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation

M.D. Anderson Cancer Center

Status and phase

Enrolling

Phase 1

Conditions

Stage IIIB Lung Cancer AJCC v8

Stage IIIA Lung Cancer AJCC v8

Stage III Lung Cancer AJCC v8

Locally Advanced Lung Non-Small Cell Carcinoma

Stage IIIC Lung Cancer AJCC v8

Treatments

Other: Questionnaire Administration

Procedure: Exercise Cardiac Stress Test

Procedure: Computed Tomography

Procedure: Single Photon Emission Computed Tomography

Procedure: Biospecimen Collection

Procedure: 6 Minute Walk Functional Test

Procedure: Echocardiography

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05010109

1R01HL157273-01 (U.S. NIH Grant/Contract)

NCI-2021-02280 (Registry Identifier)

2021-0071 (Other Identifier)

Details and patient eligibility

About

This study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. The goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. Researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.

Full description

PRIMARY OBJECTIVE:

I.To longitudinally assess cardiac injury (serum biomarkers, and grade >=2 cardiac events), and overall cardiac fitness (6-minute-walk test) in LA-NSCLC patients receiving chemoradiation.

OUTLINE:

Patients undergo single photon emission computed tomography (SPECT)/computed tomography (CT) with stress test and echocardiogram with strain before radiation therapy (RT), 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 minute walk test (MWT) before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT.

After completion of study treatment, patients are followed up annually for up to 10 years.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (L-SCLC)
The recommended treatment is thoracic radiation therapy combined with concurrent systemic therapy (chemotherapy and/or immunotherapy) with or without neoadjuvant and/or adjuvant systemic therapy (chemotherapy, immunotherapy, targeted therapy)
>/= 18 years of age
KPS >/= 70
Willing and able to sign informed consents
Willing to perform 6minute walking test
Willing to preform required cardiac biomarker test for primary end point assessment.

Exclusion criteria

Unable or unwilling to give written informed consent
Previous history of RT to the thorax overlapping with the current treatment field.
Pregnant or breast-feeding
Renal failure necessitating dialysis
Unwilling to perform protocol tests
Contraindication for any protocol tests

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Standard Treatment Plan (Cohort One)

Experimental group

Description:

Patients undergo SPECT/CT with stress test and echocardiogram with strain before RT, 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 MWT before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT.

Treatment: