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Trial record 3 of 42 for:    Heart Block | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes in Non-metastatic, Non-recurrent Lung and Esophageal Cancer Patients

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ClinicalTrials.gov Identifier: NCT04183218
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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 Non-Metastatic 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 Procedure: Biospecimen Collection Device: Cardiac Event Monitor Other: Chemoradiotherapy Radiation: Radiation Therapy

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.


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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : September 23, 2021
Estimated Study Completion Date : September 23, 2021

Resource links provided by the National Library of Medicine


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.
Procedure: Biospecimen Collection
Undergo biospecimen collection

Device: Cardiac Event Monitor
Receive cardiac monitor

Other: Chemoradiotherapy
Undergo CRT
Other Names:
  • chemoradiation
  • CRT
  • CRTx
  • Radiochemotherapy
  • RCTx
  • RT-CT

Radiation: Radiation Therapy
Undergo RT
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation




Primary Outcome Measures :
  1. Cardiac event rate at 12 months [ Time Frame: Up to 12 months ]
    The proportion of failures (cardiac event) will be estimated by the number of cardiac events divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987).


Secondary Outcome Measures :
  1. Incidence of acute adverse events (AE) [ Time Frame: Within the first 6 months from the date of enrollment ]
    Descriptive statistics of frequency (percentage) will be used to summarize AE incidence and severity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0. 95% confidence intervals will be constructed around point estimates.

  2. Incidence of late adverse events [ Time Frame: After the first 6 months from the date of enrollment ]
    Descriptive statistics of frequency (percentage) will be used to summarize AE incidence and severity as measured by the CTCAE 5.0. 95% confidence intervals will be constructed around point estimates.

  3. Loco-regional recurrence [ Time Frame: Up to 12 months ]
    Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.

  4. Distant recurrence [ Time Frame: Up to 12 months ]
    Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.

  5. Disease-free survival [ Time Frame: From study registration any local, regional, distant failure, or death, assessed up to 12 months ]
    Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.

  6. Cause specific survival [ Time Frame: From registration to death due to cancer, assessed up to 12 months ]
    Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.

  7. Cardiac event free survival [ Time Frame: From registration to cardiac event or death, assessed up to 12 months ]
    Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.

  8. Cardiac death [ Time Frame: From registration to death due to cardiac reasons, assessed up to 12 months ]
    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. Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.

  9. Overall survival [ Time Frame: From registration to death due to any cause, assessed up to 12 months ]
    Analyses will be descriptive in nature. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher's exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.


Other Outcome Measures:
  1. Imaging changes [ Time Frame: Baseline up to 12 months ]
    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.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Non-metastatic, non-recurrent lung and esophageal cancer patients who are receiving thoracic radiotherapy
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183218


Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Carlos E. Vargas         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Carlos E Vargas Mayo Clinic

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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04183218     History of Changes
Other Study ID Numbers: MC1723
NCI-2019-07938 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1723 ( Other Identifier: Mayo Clinic in Arizona )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases