Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-23

Study Completion Date

2024-05-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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 Localized Esophageal Carcinoma Localized Lung Carcinoma 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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo biospecimen collection

Cardiac Event Monitor

Intervention Type DEVICE

Receive cardiac monitor

Chemoradiotherapy

Intervention Type OTHER

Undergo CRT

Radiation Therapy

Intervention Type RADIATION

Undergo RT

Interventions

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Biospecimen Collection

Undergo biospecimen collection

Intervention Type PROCEDURE

Cardiac Event Monitor

Receive cardiac monitor

Intervention Type DEVICE

Chemoradiotherapy

Undergo CRT

Intervention Type OTHER

Radiation Therapy

Undergo RT

Intervention Type RADIATION

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Chemoradiation CRT CRTx Radiochemotherapy RCTx RT-CT Cancer Radiotherapy ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No