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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07938 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC1723 | Other Identifier | Mayo Clinic in Arizona | |
| 17-008401 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo biospecimen collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With a Cardiac Event at 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Loco-regional Recurrence | 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. | Up to 12 months |
| Disease-free Survival |
| Measure | Description | Time Frame |
|---|---|---|
| Imaging Changes | 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. | Baseline up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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Non-metastatic, non-recurrent lung and esophageal cancer patients who are receiving thoracic radiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Carlos E. Vargas, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: Undergo biospecimen collection> > Cardiac Event Monitor: Receive cardiac monitor> > Chemoradiotherapy: Undergo CRT> > Radiation Therapy: Undergo RT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2024 |
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Blood
| Cardiac Event Monitor | Device | Receive cardiac monitor |
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| Chemoradiotherapy | Other | Undergo CRT |
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| Radiation Therapy | Radiation | Undergo RT |
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Disease- free survival is defined as the time from study registration until any disease recurrence or death.
| Up to 12 months |
| Distant Recurrence | 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. | Up to 12 months |
| Cardiac Event Free Survival | Cardiac event free survival is defined as the time from registration to any cardiac> event or death. | Up to 12 months |
| Cardiac Death | 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. | Up to 12 months |
| Overall Survival | Overall survival is defined as the time from registration to death due to any cause. | Up to 12 months |
| Incidence of Acute 3+ Adverse Events (AE) | Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0. | Within the first 6 months from the date of enrollment |
| Incidence of Late Grade 3+ Adverse Events | Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0. | After the first 6 months from the date of enrollment |
| Cause Specific Survival | Cause specific survival is defined as the time from registration to death due to cancer. | Up to 12 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: Undergo biospecimen collection> > Cardiac Event Monitor: Receive cardiac monitor> > Chemoradiotherapy: Undergo CRT> > Radiation Therapy: Undergo RT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Recurrence | Count of Participants | Participants |
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| Prior Surgery | Count of Participants | Participants |
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| Prior Radiation | Count of Participants | Participants |
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| Prior Systemic Treatment | Count of Participants | Participants |
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| Smoking history | Count of Participants | Participants |
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| Has the patient had any (other) prior cancer diagnosed? | Count of Participants | Participants |
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| Site of prior cancer | Count of Participants | Participants |
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| Prior treatment regimen type | Count of Participants | Participants |
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| Weight (kg) | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| Height (cm) | Mean | Standard Deviation | cm |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With a Cardiac Event at 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. | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 12 months |
|
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| ||||||||||||||||||||||||||
| Secondary | Loco-regional Recurrence | 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. | Posted | Count of Participants | Participants | Up to 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Disease-free Survival | Disease- free survival is defined as the time from study registration until any disease recurrence or death. | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Distant Recurrence | 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. | Posted | Count of Participants | Participants | Up to 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Cardiac Event Free Survival | Cardiac event free survival is defined as the time from registration to any cardiac> event or death. | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Cardiac Death | 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. | Posted | Count of Participants | Participants | Up to 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the time from registration to death due to any cause. | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Acute 3+ Adverse Events (AE) | Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0. | Posted | Number | adverse events | Within the first 6 months from the date of enrollment |
|
| ||||||||||||||||||||||||||||
| Secondary | Incidence of Late Grade 3+ Adverse Events | Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0. | Posted | Count of Participants | Participants | After the first 6 months from the date of enrollment |
|
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| Secondary | Cause Specific Survival | Cause specific survival is defined as the time from registration to death due to cancer. | Posted | Count of Participants | Participants | Up to 12 months |
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| Other Pre-specified | Imaging Changes | 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. | Not Posted | Baseline up to 12 months | Participants |
Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational (Cardiac Monitoring) | Radiation Therapy: Undergo RT | 4 | 24 | 4 | 24 | 22 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death NOS | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Disease progression | General disorders | CTCAE 5 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 5 | Systematic Assessment |
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| Aortic valve disease | Cardiac disorders | CTCAE 5 | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | CTCAE 5 | Systematic Assessment |
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| Conduction disorder | Cardiac disorders | CTCAE 5 | Systematic Assessment |
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| Heart failure | Cardiac disorders | CTCAE 5 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | CTCAE 5 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
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| Esophageal pain | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
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| Esophagitis | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
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| Gastric necrosis | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE 5 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE 5 | Systematic Assessment |
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| Pain | General disorders | CTCAE 5 | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE 5 | Systematic Assessment |
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| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
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| Gastric anastomotic leak | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE 5 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos E. Vargas | Mayo Clinic | 480-342-1262 | vargas.carlos@mayo.edu |
| Jan 26, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 21, 2022 | Jan 26, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D059248 | Chemoradiotherapy |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D055585 | Physical Phenomena |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Current |
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| Unknown |
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| Melanoma, upper back (2019); BCC upper back (no date) |
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| Prostate |
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| Right Nare BCC |
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| Squamous cell carcinoma of the ear |
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| Thyroid cancer |
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| Missing |
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| Prostatectomy |
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| Prostatectomy; adjuvant radiation |
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| Thyroidectomy, I-131 therapy - 2005. |
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| Wedge excision |
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| unknown method of removal |
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| Missing |
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