Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

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: Completed
• Conditions: Stage III Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB 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 IIIC Lung Cancer AJCC v8; 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 III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8; 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; Clinical Stage IIB Esophageal Adenocarcinoma 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; Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8; Localized Esophageal Carcinoma; Localized Lung Carcinoma; Postneoadjuvant Therapy Stage I Esophageal Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage I Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma AJCC v8; Stage 0 Lung Cancer AJCC v8
• Intervention / Treatment: Radiation: Radiation Therapy; Procedure: Biospecimen Collection; Device: Cardiac Event Monitor; Other: Chemoradiotherapy

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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
Proportion of Participants With a Cardiac Event at 12 Months	Assessed as any cardiac event after registration, including electrophysiological changes as defined by the continuous insertable cardiac monitor (ICM); congestive heart failure (CHF); myocardial infarction; pericarditis or myocarditis; cardiac ablation or cardiac pacemaker; cardiac stent placement or any coronary procedure for coronary damage; or any cardiac event as defined by the patients' medical records or autopsy if done.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loco-regional Recurrence	Loco-regional recurrence is defined as local recurrences of the cancer in the> same location where the disease was found on any diagnostic or> staging study.	Up to 12 months
Disease-free Survival	Disease- free survival is defined as the time from study registration until any disease recurrence or death.	Up to 12 months
Distant Recurrence	Distant recurrence is defined as metastatic cancer (cancer that has spread to organs or tissues far from the original cancer) that has either been biopsy> confirmed or clinically diagnosed as recurrent.	Up to 12 months
Cardiac Event Free Survival	Cardiac event free survival is defined as the time from registration to any cardiac> event or death.	Up to 12 months
Cardiac Death	Cardiac death is defined as the time from registration to death due to cardiac> reasons. 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. *Any lethal electrophysiologic change documented by before death would also be included.	Up to 12 months
Overall Survival	Overall survival is defined as the time from registration to death due to any cause.	Up to 12 months
Incidence of Acute 3+ Adverse Events (AE)	Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0.	Within the first 6 months from the date of enrollment
Cause Specific Survival	Cause specific survival is defined as the time from registration to death due to cancer.	Up to 12 months
Incidence of Late Grade 3+ Adverse Events	Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0.	After the first 6 months from the date of enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Carlos E. Vargas, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): January 6, 2024
• Study Completion (Actual): May 2, 2024

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): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drug Therapy; Physical Phenomena; Combined Modality Therapy; Radiotherapy; Radiation; Specimen Handling; Chemoradiotherapy
• 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
• product manufactured in and exported from the U.S.: No