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Spots Global Cancer Trial Database for Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

Official Title: Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

Study ID: NCT04183218

Conditions

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 Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Contact Details

Name: Carlos E. Vargas, M.D.

Affiliation: Mayo Clinic

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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