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 IIA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Squamous Cell Carcinoma 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 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 I Esophageal Adenocarcinoma AJCC v8, Pathologic Stage I 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 II Esophageal Adenocarcinoma AJCC v8, Pathologic Stage II 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, Pathologic Stage III Esophageal Adenocarcinoma AJCC v8, Pathologic Stage III 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 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, Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8, Stage 0 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 IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8
Conditions
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.
Interventions
Undergo biospecimen collection
Receive cardiac monitor
Undergo CRT
Undergo RT
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With a Cardiac Event at 12 Months | Up to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loco-regional Recurrence | Up to 12 months | 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. |
| Disease-free Survival | Up to 12 months | Disease- free survival is defined as the time from study registration until any disease recurrence or death. |
| Distant Recurrence | Up to 12 months | 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. |
| Cardiac Event Free Survival | Up to 12 months | Cardiac event free survival is defined as the time from registration to any cardiac\> event or death. |
| Cardiac Death | Up to 12 months | 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. |
| Overall Survival | Up to 12 months | Overall survival is defined as the time from registration to death due to any cause. |
| Incidence of Acute 3+ Adverse Events (AE) | Within the first 6 months from the date of enrollment | Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0. |
| Incidence of Late Grade 3+ Adverse Events | After the first 6 months from the date of enrollment | Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0. |
| Cause Specific Survival | Up to 12 months | Cause specific survival is defined as the time from registration to death due to cancer. |
Countries
United States
Contacts
Mayo Clinic
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.046 years STANDARD_DEVIATION 9.511 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Has the patient had any (other) prior cancer diagnosed? No | 14 Participants |
| Has the patient had any (other) prior cancer diagnosed? Yes | 8 Participants |
| Height (cm) | 171.529 cm STANDARD_DEVIATION 9.983 |
| Prior Radiation No | 21 Participants |
| Prior Radiation Yes | 1 Participants |
| Prior Surgery No | 10 Participants |
| Prior Surgery Yes | 12 Participants |
| Prior Systemic Treatment No | 17 Participants |
| Prior Systemic Treatment Yes | 5 Participants |
| Prior treatment regimen type Excision | 2 Participants |
| Prior treatment regimen type Hysterectomy | 1 Participants |
| Prior treatment regimen type Missing | 14 Participants |
| Prior treatment regimen type Prostatectomy | 1 Participants |
| Prior treatment regimen type Prostatectomy; adjuvant radiation | 1 Participants |
| Prior treatment regimen type Thyroidectomy, I-131 therapy - 2005. | 1 Participants |
| Prior treatment regimen type unknown method of removal | 1 Participants |
| Prior treatment regimen type Wedge excision | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Recurrence No | 22 Participants |
| Recurrence Yes | 0 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 9 Participants |
| Site of prior cancer Cervix | 1 Participants |
| Site of prior cancer Lung, Right upper lobe | 1 Participants |
| Site of prior cancer Melanoma, upper back (2019); BCC upper back (no date) | 1 Participants |
| Site of prior cancer Missing | 14 Participants |
| Site of prior cancer Prostate | 2 Participants |
| Site of prior cancer Right Nare BCC | 1 Participants |
| Site of prior cancer Squamous cell carcinoma of the ear | 1 Participants |
| Site of prior cancer Thyroid cancer | 1 Participants |
| Smoking history Current | 1 Participants |
| Smoking history Never | 6 Participants |
| Smoking history Previous | 15 Participants |
| Smoking history Unknown | 0 Participants |
| Weight (kg) | 86.514 kg STANDARD_DEVIATION 20.705 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 24 |
| other Total, other adverse events | 22 / 24 |
| serious Total, serious adverse events | 4 / 24 |