Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

Stage III Lung Cancer AJCC v8 Clinical Trial

Official title:

Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04183218
• Other study ID #: MC1723
• Secondary ID: NCI-2019-07938MC
• Status: Active, not recruiting
• Start date: September 23, 2019
• Est. completion date: September 23, 2025

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 23, 2025
• Est. primary completion date: September 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Squamous Cell
• Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8
• Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage I Esophageal Adenocarcinoma AJCC v8
• Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage II Esophageal Adenocarcinoma AJCC v8
• Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
• Clinical Stage III Esophageal Adenocarcinoma AJCC v8
• Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Localized Lung Carcinoma
• Lung Neoplasms
• Pathologic Stage 0 Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage I Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage I Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage I Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
• Stage 0 Lung Cancer AJCC v8
• Stage I Lung Cancer AJCC v8
• Stage IA1 Lung Cancer AJCC v8
• Stage IA2 Lung Cancer AJCC v8
• Stage IA3 Lung Cancer AJCC v8
• Stage IB Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage IIA Lung Cancer AJCC v8
• Stage IIB Lung Cancer AJCC v8
• 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:
• Biospecimen Collection
Undergo biospecimen collection

Device:
• Cardiac Event Monitor
Receive cardiac monitor

Other:
• Chemoradiotherapy
Undergo CRT

Radiation:
• Radiation Therapy
Undergo RT

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Imaging changes	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
Primary	Cardiac event rate at 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	Incidence of acute adverse events (AE)	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
Secondary	Incidence of late adverse events	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
Secondary	Loco-regional recurrence	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
Secondary	Distant recurrence	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
Secondary	Disease-free survival	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
Secondary	Cause specific survival	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
Secondary	Cardiac event free survival	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
Secondary	Cardiac death	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
Secondary	Overall survival	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

External Links

•   Mayo Clinic Clinical Trials