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NCT Number: NCT05010109

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Zhongxing Liao

CONTACT

[email protected]

832-829-5312

Zhongxing Liao

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6 Minute Walk Functional Test

Procedure

Participate in 6 MWT

Other names: 6MWT, SIX MINUTE WALK, SIXMW1

Biospecimen Collection

Procedure

Undergo blood and urine sample collection

Computed Tomography

Procedure

Undergo SPECT/CT

Other names: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Echocardiography

Procedure

Undergo echocardiogram

Other names: ECHO_TEST

Exercise Cardiac Stress Test

Procedure

Undergo stress test

Other names: ECST, Exercise Stress Test

Questionnaire Administration

Other

Complete questionnaires

Single Photon Emission Computed Tomography

Procedure

Undergo SPECT/CT

Other names: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon

Primary outcomes

  1. Increase in level of hs-TnT >= 5ng/L

    Time frame: up to 24 months

    Baseline up to end or chemoradiation (CRT)

  2. Incidence of grade >= 2 cardiovascular events

    Time frame: Within 12-month of completion of CRT]

    Defined by Common Terminology Criteria for Adverse Events version 5.0.

Secondary outcomes

  1. Overall cardiac fitness

    Time frame: Up to 24 months after CRT

    Assessed using 6 minute walk test.

  2. EuroQol 5 Dimension 5 Level: Patient reported outcomes

    Time frame: Up to 24 months after CRT

    Score Range 0-100 (0) Worst health and (100) best health Level 1- No complaints Level 5- Worst

  3. MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes

    Time frame: Up to 24 months after CRT

    Score Range 0-10 (0) No symptom and (10) worst symptoms

  4. Overall survival

    Time frame: Up to 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongxing Liao, MD

CONTACT

[email protected]

832-829-5312

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Longitudinal Assessment of Cardiovascular Injury and Cardiac Fitness in LA-NSCLC Patients Receiving Model Based Personalized Chemoradiation - an Adaptive Cohort Registration Study

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 18, 2021
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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