Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

September 20, 2023 updated by: Mayo Clinic
This trial studies cardiac changes after radiation or chemo-radiation for the treatment of lung or esophageal cancer that has not spread to other places in the body (non-metastatic) or has not come back (non-recurrent). Continuous cardiac monitoring with an implanted device may help to identify cardiac changes that would remain unnoticed, and facilitate the treatment of these early cardiac changes as part of standard care.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer.

EXPLORATORY OBJECTIVES:

I. Define the spectrum of cardiac toxicity among chemoradiotherapy (CRT) patients at highest risk of cardiac toxicity.

II. Establish the timeline of cardiac toxicity development and identify early predictive findings of permanent damage.

III. Characterize the areas of the heart at highest risk for persistent cardiac damage.

IV. Identify a dose response threshold for radiotherapy (RT) damage in different areas of the heart.

V. Improve survival by alerting the cardiology team of the need for life-saving standard of care interventions.

VI. Describe medical interventions employed for the cardiac events identified in the study.

OUTLINE:

Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months.

After completion of study treatment, patients are followed up at 4 weeks, 3, 9 and 12 months post RT.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

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

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

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

Sampling Method

Probability Sample

Study Population

Non-metastatic, non-recurrent lung and esophageal cancer patients who are receiving thoracic radiotherapy

Description

Inclusion Criteria:

  • Age >= 18 years
  • Planned standard of care curative thoracic RT or CRT with anticipated heart V40 > 20 cc (At least 20 cc of the heart should receive a dose of 40 gray [Gy] or higher)
  • Able to follow-up at all specified standard of care time-points
  • Patients can receive treatment as part of the standard of care or in a different study
  • Receiving radiation treatment to an area close to the heart, for example gastroesophageal junction cancer, hilar lung cancer, or mainstem bronchus lung cancer
  • Any type of systemic therapy or surgery before during or after radiation is acceptable
  • Prior radiation to other areas is acceptable
  • Planned radiation doses equal or higher than 40 Gy

Exclusion Criteria:

  • Metastatic disease
  • Recurrent disease
  • Patient receiving radiation prescription doses lower than 40 Gy
  • No prior radiation that included any part of the heart is acceptable
  • No thoracic re-irradiation

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (cardiac monitoring)
Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months.
Radiation: Radiation Therapy
Undergo RT
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
Procedure: Biospecimen Collection
Undergo biospecimen collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Device: Cardiac Event Monitor
Receive cardiac monitor
Other: Chemoradiotherapy
Undergo CRT
Other Names:
  • CRT
  • Chemoradiation
  • CRTx
  • Radiochemotherapy
  • RCTx
  • RT-CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac event rate at 12 months
Time Frame: Up to 12 months
The proportion of failures (cardiac event) will be estimated by the number of cardiac events divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987).
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute adverse events (AE)
Time Frame: Within the first 6 months from the date of enrollment
Descriptive statistics of frequency (percentage) will be used to summarize AE incidence and severity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0. 95% confidence intervals will be constructed around point estimates.
Within the first 6 months from the date of enrollment
Incidence of late adverse events
Time Frame: After the first 6 months from the date of enrollment
Descriptive statistics of frequency (percentage) will be used to summarize AE incidence and severity as measured by the CTCAE 5.0. 95% confidence intervals will be constructed around point estimates.
After the first 6 months from the date of enrollment
Loco-regional recurrence
Time Frame: Up to 12 months
Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
Up to 12 months
Distant recurrence
Time Frame: Up to 12 months
Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
Up to 12 months
Disease-free survival
Time Frame: From study registration any local, regional, distant failure, or death, assessed up to 12 months
Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
From study registration any local, regional, distant failure, or death, assessed up to 12 months
Cause specific survival
Time Frame: From registration to death due to cancer, assessed up to 12 months
Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
From registration to death due to cancer, assessed up to 12 months
Cardiac event free survival
Time Frame: From registration to cardiac event or death, assessed up to 12 months
Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
From registration to cardiac event or death, assessed up to 12 months
Cardiac death
Time Frame: From registration to death due to cardiac reasons, assessed up to 12 months
Cardiac death would include documented congestive heart failure, myocardial infarction, arrhythmia, heart block, or any other cardiac cause documented in the medical records, death certificate, or autopsy as one of the major contributing causes of death. Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
From registration to death due to cardiac reasons, assessed up to 12 months
Overall survival
Time Frame: From registration to death due to any cause, assessed up to 12 months
Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
From registration to death due to any cause, assessed up to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging changes
Time Frame: Baseline up to 12 months
Imaging changes in the heart substructures associated with occurrence of cardiac events will be an exploratory component of this trial. Changes will be described at each time point using frequency distributions.
Baseline up to 12 months

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Carlos E. Vargas, M.D., Mayo Clinic

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)

September 23, 2019

Primary Completion (Estimated)

September 23, 2024

Study Completion (Estimated)

September 23, 2025

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

November 27, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC1723 (Other Identifier: Mayo Clinic in Arizona)
  • NCI-2019-07938 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 17-008401 (Other Identifier: Mayo Clinic Institutional Review Board)

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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