Recruiting

Chemoradiation

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05010109

Conditions

Locally Advanced Lung Non-Small Cell Carcinoma

Stage III Lung Cancer AJCC v8

Stage IIIA Lung Cancer AJCC v8

Stage IIIB Lung Cancer AJCC v8

Stage IIIC Lung Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

6 Minute Walk Functional Test

Biospecimen Collection

Computed Tomography

Echocardiography

Exercise Cardiac Stress Test

Study Details

Brief summary:

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.

Conditions

Locally Advanced Lung Non-Small Cell Carcinoma

Stage III Lung Cancer AJCC v8

Stage IIIA Lung Cancer AJCC v8

Stage IIIB Lung Cancer AJCC v8

Stage IIIC Lung Cancer AJCC v8

Study ID

NCT05010109

Start date

Jul 5, 2021

Status verified date

Mar, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (L-SCLC)
2. 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)
3. >/= 18 years of age
4. KPS >/= 70
5. Willing and able to sign informed consents
6. Willing to perform 6minute walking test
7. Willing to preform required cardiac biomarker test for primary end point assessment.

Exclusion criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Standard Treatment Plan (Cohort One)

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.

experimental: Model Based Personalized Treatment Plan (Cohort Two)

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.

Interventions

6 Minute Walk Functional Test

Participate in 6 MWT

Biospecimen Collection

Undergo blood and urine sample collection

Computed Tomography

Undergo SPECT/CT

Echocardiography

Undergo echocardiogram

Exercise Cardiac Stress Test

Undergo stress test

Questionnaire Administration

Complete questionnaires

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Primary outcome measure

  • Increase in level of hs-TnT >= 5ng/L [ Time Frame: up to 24 months ]
  • Incidence of grade >= 2 cardiovascular events [ Time Frame: Within 12-month of completion of CRT] ]

Central Contacts and Locations

Central contacts

Zhongxing Liao, MD

832-829-5312zliao@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Zhongxing Liao

832-829-5312zliao@mdanderson.org

Principal Investigator:

Zhongxing Liao

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-11.