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Recruiting NCT05010109

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

No phase Interventional 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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 6 Minute Walk Functional Test, Biospecimen Collection, Computed Tomography, Echocardiography.
Who it may be relevant to
Registry 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. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Procedure 6 Minute Walk Functional Test
    Participate in 6 MWT
  • Procedure Biospecimen Collection
    Undergo blood and urine sample collection
  • Procedure Computed Tomography
    Undergo SPECT/CT
  • Procedure Echocardiography
    Undergo echocardiogram
  • Procedure Exercise Cardiac Stress Test
    Undergo stress test
  • Other Questionnaire Administration
    Complete questionnaires
  • Procedure Single Photon Emission Computed Tomography
    Undergo SPECT/CT

Primary outcome measures

  • 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]]
Secondary outcome measures (4)
  • Overall cardiac fitness [Time frame: Up to 24 months after CRT]
  • EuroQol 5 Dimension 5 Level: Patient reported outcomes [Time frame: Up to 24 months after CRT]
  • MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes [Time frame: Up to 24 months after CRT]
  • Overall survival [Time frame: Up to 10 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT05010109 · 2021-0071 · NCI-2021-02280 · 2021-0071 · 1R01HL157273-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗