Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes in Non-metastatic, Non-recurrent Lung and Esophageal Cancer Patients
Study Details
Study Description
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVE:
- To determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer.
EXPLORATORY OBJECTIVES:
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Define the spectrum of cardiac toxicity among chemoradiotherapy (CRT) patients at highest risk of cardiac toxicity.
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Establish the timeline of cardiac toxicity development and identify early predictive findings of permanent damage.
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Characterize the areas of the heart at highest risk for persistent cardiac damage.
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Identify a dose response threshold for radiotherapy (RT) damage in different areas of the heart.
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Improve survival by alerting the cardiology team of the need for life-saving standard of care interventions.
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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 Design
Arms and Interventions
| Arm | 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. |
Procedure: Biospecimen Collection
Undergo biospecimen collection
Device: Cardiac Event Monitor
Receive cardiac monitor
Other: Chemoradiotherapy
Undergo CRT
Other Names:
Radiation: Radiation Therapy
Undergo RT
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cardiac event rate at 12 months [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).
Secondary Outcome Measures
- Incidence of acute adverse events (AE) [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.
- Incidence of late adverse events [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.
- Loco-regional recurrence [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.
- Distant recurrence [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.
- Disease-free survival [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.
- Cause specific survival [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.
- Cardiac event free survival [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.
- Cardiac death [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.
- Overall survival [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.
Other Outcome Measures
- Imaging changes [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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Able to follow-up at all specified standard of care time-points
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Patients can receive treatment as part of the standard of care or in a different study
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Receiving radiation treatment to an area close to the heart, for example gastroesophageal junction cancer, hilar lung cancer, or mainstem bronchus lung cancer
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Any type of systemic therapy or surgery before during or after radiation is acceptable
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Prior radiation to other areas is acceptable
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Planned radiation doses equal or higher than 40 Gy
Exclusion Criteria:
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Metastatic disease
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Recurrent disease
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Patient receiving radiation prescription doses lower than 40 Gy
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No prior radiation that included any part of the heart is acceptable
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No thoracic re-irradiation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Carlos E Vargas, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MC1723
- NCI-2019-07938
- MC1723
- P30CA015083