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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.


Clinical Trial 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 Design


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

NCT number NCT04183218
Study type Observational
Source Mayo Clinic
Contact
Status Active, not recruiting
Phase
Start date September 23, 2019
Completion date September 23, 2025

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