Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

Completed

• Conditions: Clinical Stage II Esophageal Adenocarcinoma AJCC V8; Clinical Stage III Esophageal Adenocarcinoma AJCC V8; Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC V8; Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC V8; Stage IA1 Lung Cancer AJCC V8; Stage III Lung Cancer AJCC V8; Clinical Stage IIA Esophageal Adenocarcinoma AJCC V8; Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC V8; Pathologic Stage 0 Esophageal Adenocarcinoma AJCC V8; Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC V8

• Registration Number: NCT04183218
• Lead Sponsor: Mayo Clinic

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:

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 Timeline

• Study Start: 2019-09-23
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-12-03
• Primary Completion: 2024-01-06
• Study Completion: 2024-05-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac event rate at 12 months	Up to 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.

Secondary Outcome Measures

Name	Time	Method
Cause specific survival	Up to 12 months	Cause specific survival is defined as the time from registration to death due to cancer.
Disease-free survival	Up to 12 months	Disease- free survival is defined as the time from study registration until any disease recurrence or death.
Incidence of late adverse events	After the first 6 months from the date of enrollment	Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Distant recurrence	Up to 12 months	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.
Cardiac event free survival	Up to 12 months	Cardiac event free survival is defined as the time from registration to any cardiac event or death.
Cardiac death	Up to 12 months	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.
Loco-regional recurrence	Up to 12 months	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.
Overall survival	Up to 12 months	Overall survival is defined as the time from registration to death due to any cause.
Incidence of acute adverse events (AE)	Within the first 6 months from the date of enrollment	Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0.