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

August 23, 2023 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 locally advanced (LA)-non-small cell lung cancer (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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Zhongxing Liao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with histologic diagnosis of non-small cell lung cancer
  • 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
  • Karnofsky performance status (KPS) >= 70
  • Willing and able to sign informed consents
  • Able and willing to perform 6minute walking test
  • Able and willing to preform required cardiac imaging examinations

Exclusion Criteria:

  • Unable or unwilling to give written informed consent
  • Previous history of RT to the thorax
  • Any contraindication for cardiac imaging
  • Pregnant or breast-feeding
  • Renal failure necessitating dialysis
  • Unable to perform protocol tests
  • Contraindication for any protocol tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Echocardiography
Undergo echocardiogram
Other Names:
  • ECHO_TEST
Other: Questionnaire Administration
Complete questionnaires
Procedure: 6 Minute Walk Functional Test
Participate in 6 MWT
Other Names:
  • 6MWT
  • SIX MINUTE WALK
  • SIXMW1
Procedure: Biospecimen Collection
Undergo blood and urine sample collection
Procedure: Computed Tomography
Undergo SPECT/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
Procedure: Exercise Cardiac Stress Test
Undergo stress test
Other Names:
  • ECST
  • Exercise Stress Test
Procedure: Single Photon Emission Computed Tomography
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
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.
Procedure: Echocardiography
Undergo echocardiogram
Other Names:
  • ECHO_TEST
Other: Questionnaire Administration
Complete questionnaires
Procedure: 6 Minute Walk Functional Test
Participate in 6 MWT
Other Names:
  • 6MWT
  • SIX MINUTE WALK
  • SIXMW1
Procedure: Biospecimen Collection
Undergo blood and urine sample collection
Procedure: Computed Tomography
Undergo SPECT/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
Procedure: Exercise Cardiac Stress Test
Undergo stress test
Other Names:
  • ECST
  • Exercise Stress Test
Procedure: Single Photon Emission Computed Tomography
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in level of hs-TnT >= 5ng/L
Time Frame: up to 24 months
Baseline up to end or chemoradiation (CRT)
up to 24 months
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.
Within 12-month of completion of CRT]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 10 years
Up to 10 years
Overall cardiac fitness
Time Frame: Up to 24 months after CRT
Assessed using 6 minute walk test.
Up to 24 months after CRT
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
Up to 24 months after CRT
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
Up to 24 months after CRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Zhongxing Liao, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2021

Primary Completion (Estimated)

February 23, 2026

Study Completion (Estimated)

February 23, 2026

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0071 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-02280 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 1R01HL157273-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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