Locally Advanced Lung Non-Small Cell CarcinomaNCT05010109

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

A study testing 6 Minute Walk Functional Test, Biospecimen Collection and Computed Tomography in people with Locally Advanced Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8
What is being tested?: 6 Minute Walk Functional Test, Biospecimen Collection and Computed Tomography
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 5 Jul 2021to 2 Feb 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhongxing Liao, MD contact

832-829-5312

zliao@mdanderson.org

United States1 site, 1 recruiting

M D Anderson Cancer Center
Houston, Texas, 77030
Zhongxing Liao, 832-829-5312, zliao@mdanderson.org
Zhongxing Liao
Recruiting

Other trials in United States

About this study

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

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.

Read the detailed 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.

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
Being tested: 6 Minute Walk Functional Test, Biospecimen Collection, Computed Tomography, Echocardiography, Exercise Cardiac Stress Test
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

6 Minute Walk Functional TestProcedure or surgery
Also called 6MWT, SIX MINUTE WALK, SIXMW1
Participate in 6 MWT
Biospecimen CollectionProcedure or surgery
Undergo blood and urine sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo SPECT/CT
EchocardiographyProcedure or surgery
Also called ECHO_TEST
Undergo echocardiogram
Exercise Cardiac Stress TestProcedure or surgery
Also called ECST, Exercise Stress Test
Undergo stress test
Questionnaire AdministrationOther
Complete questionnaires
Single Photon Emission Computed TomographyProcedure or surgery
Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT
Undergo SPECT/CT

Study groups in NCT05010109
Study group	Role	What they receive
Standard Treatment Plan (Cohort One)	Experimental	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. Receives: Procedure: 6 Minute Walk Functional Test; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography; Procedure: Exercise Cardiac Stress Test; Other: Questionnaire Administration; Procedure: Single Photon Emission Computed Tomography
Model Based Personalized Treatment Plan (Cohort Two)	Experimental	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. Receives: Procedure: 6 Minute Walk Functional Test; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography; Procedure: Exercise Cardiac Stress Test; Other: Questionnaire Administration; Procedure: Single Photon Emission Computed Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

Increase in level of hs-TnT >= 5ng/L
Baseline up to end or chemoradiation (CRT)
Measured: up to 24 months
Incidence of grade >= 2 cardiovascular events
Defined by Common Terminology Criteria for Adverse Events version 5.0.
Measured: Within 12-month of completion of CRT]

Secondary outcomes (4)

Overall cardiac fitness
Assessed using 6 minute walk test.
Measured: Up to 24 months after CRT
EuroQol 5 Dimension 5 Level: Patient reported outcomes
Score Range 0-100 (0) Worst health and (100) best health Level 1- No complaints Level 5- Worst
Measured: Up to 24 months after CRT
MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes
Score Range 0-10 (0) No symptom and (10) worst symptoms
Measured: Up to 24 months after CRT
Overall survival
Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 20212 Feb 2027

First posted18 Aug 2021
Study start5 Jul 2021
Primary completion2 Feb 2027 (estimated)
Study completion2 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Locally Advanced Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05010109
Sponsor's protocol ID: 2021-0071
Other IDs: NCI-2021-02280, 2021-0071, 1R01HL157273-01
Status last verified: Sep 2026
First submitted: 12 Apr 2021
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Zhongxing Liao, MD

832-829-5312

zliao@mdanderson.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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