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

ConditionsLocally Advanced Lung Non-Small Cell CarcinomaStage III Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 6 Minute Walk Functional Test

    Procedure/Surgery

    Participate in 6 MWT

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo SPECT/CT

  • Echocardiography

    Procedure/Surgery

    Undergo echocardiogram

  • Exercise Cardiac Stress Test

    Procedure/Surgery

    Undergo stress test

  • Questionnaire Administration

    Other intervention

    Complete questionnaires

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT/CT

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Standard Treatment Plan (Cohort One)Experimental treatment 7 interventions
Group B: Model Based Personalized Treatment Plan (Cohort Two)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

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

Baseline up to end or chemoradiation (CRT)

Time frame
up to 24 months
2

Incidence of grade >= 2 cardiovascular events

Defined by Common Terminology Criteria for Adverse Events version 5.0.

Time frame
Within 12-month of completion of CRT]

Secondary outcomes

1

Overall cardiac fitness

Assessed using 6 minute walk test.

Time frame
Up to 24 months after CRT
2

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

Time frame
Up to 24 months after CRT
3

MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes

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

Time frame
Up to 24 months after CRT
4

Overall survival

Time frame
Up to 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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