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

Primary Purpose

Locally Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
6 Minute Walk Functional Test
Biospecimen Collection
Computed Tomography
Echocardiography
Exercise Cardiac Stress Test
Questionnaire Administration
Single Photon Emission Computed Tomography
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Locally Advanced Lung Non-Small Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard Treatment Plan (Cohort One)

Model Based Personalized Treatment Plan (Cohort Two)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall cardiac fitness
Assessed using 6 minute walk test.
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
MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes
Score Range 0-10 (0) No symptom and (10) worst symptoms
Overall survival

Full Information

First Posted
April 12, 2021
Last Updated
August 23, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05010109
Brief Title
Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation
Official Title
Longitudinal Assessment of Cardiovascular Injury and Cardiac Fitness in LA-NSCLC Patients Receiving Model Based Personalized Chemoradiation - an Adaptive Cohort Registration Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
February 23, 2026 (Anticipated)
Study Completion Date
February 23, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Treatment Plan (Cohort One)
Arm Type
Experimental
Arm Description
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.
Arm Title
Model Based Personalized Treatment Plan (Cohort Two)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
6 Minute Walk Functional Test
Other Intervention Name(s)
6MWT, SIX MINUTE WALK, SIXMW1
Intervention Description
Participate in 6 MWT
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Intervention Description
Undergo blood and urine sample collection
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo SPECT/CT
Intervention Type
Procedure
Intervention Name(s)
Echocardiography
Other Intervention Name(s)
ECHO_TEST
Intervention Description
Undergo echocardiogram
Intervention Type
Procedure
Intervention Name(s)
Exercise Cardiac Stress Test
Other Intervention Name(s)
ECST, Exercise Stress Test
Intervention Description
Undergo stress test
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaires
Intervention Type
Procedure
Intervention Name(s)
Single Photon Emission Computed Tomography
Other Intervention Name(s)
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
Intervention Description
Undergo SPECT/CT
Primary Outcome Measure Information:
Title
Increase in level of hs-TnT >= 5ng/L
Description
Baseline up to end or chemoradiation (CRT)
Time Frame
up to 24 months
Title
Incidence of grade >= 2 cardiovascular events
Description
Defined by Common Terminology Criteria for Adverse Events version 5.0.
Time Frame
Within 12-month of completion of CRT]
Secondary Outcome Measure Information:
Title
Overall cardiac fitness
Description
Assessed using 6 minute walk test.
Time Frame
Up to 24 months after CRT
Title
EuroQol 5 Dimension 5 Level: Patient reported outcomes
Description
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
Title
MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes
Description
Score Range 0-10 (0) No symptom and (10) worst symptoms
Time Frame
Up to 24 months after CRT
Title
Overall survival
Time Frame
Up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongxing Liao, MD
Phone
832-829-5312
Email
zliao@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongxing Liao, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongxing Liao
Phone
832-829-5312
Email
zliao@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Zhongxing Liao

12. IPD Sharing Statement

Links:
URL
http://mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

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