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

Stage III Lung Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05010109
• Other study ID #: 2021-0071
• Secondary ID: NCI-2021-0228020
• Status: Recruiting
• Phase: Phase 1
• Start date: July 5, 2021
• Est. completion date: February 23, 2026

Study information

• Verified date: August 2023
• Source: M.D. Anderson Cancer Center
• Contact: Zhongxing Liao, MD
• Phone: 832-829-5312
• Email: zliao[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 23, 2026
• Est. primary completion date: February 23, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced Lung Non-Small Cell Carcinoma
• Lung Neoplasms
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8

Intervention

Procedure:
• 6 Minute Walk Functional Test
Participate in 6 MWT
• Biospecimen Collection
Undergo blood and urine sample collection
• Computed Tomography
Undergo SPECT/CT
• Echocardiography
Undergo echocardiogram
• Exercise Cardiac Stress Test
Undergo stress test

Other:
• Questionnaire Administration
Complete questionnaires

Procedure:
• Single Photon Emission Computed Tomography
Undergo SPECT/CT

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in level of hs-TnT >= 5ng/L	Baseline up to end or chemoradiation (CRT)	up to 24 months
Primary	Incidence of grade >= 2 cardiovascular events	Defined by Common Terminology Criteria for Adverse Events version 5.0.	Within 12-month of completion of CRT]
Secondary	Overall cardiac fitness	Assessed using 6 minute walk test.	Up to 24 months after CRT
Secondary	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	Up to 24 months after CRT
Secondary	MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes	Score Range 0-10 (0) No symptom and (10) worst symptoms	Up to 24 months after CRT
Secondary	Overall survival		Up to 10 years

External Links

•   MD Anderson Cancer Center