Clinical trial NCT04183218: Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
Official title: Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-metastatic, non-recurrent lung and esophageal cancer patients who are receiving thoracic radiotherapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac event rate at 12 months
timeFrame: Up to 12 months
Secondary outcomes:
measure: Loco-regional recurrence
timeFrame: Up to 12 months
measure: Disease-free survival
timeFrame: Up to 12 months
measure: Distant recurrence
timeFrame: Up to 12 months
measure: Cardiac event free survival
timeFrame: Up to 12 months
measure: Cardiac death
timeFrame: Up to 12 months
measure: Overall survival
timeFrame: Up to 12 months
measure: Incidence of acute adverse events (AE)
timeFrame: Within the first 6 months from the date of enrollment
measure: Incidence of late adverse events
timeFrame: After the first 6 months from the date of enrollment
measure: Cause specific survival
timeFrame: Up to 12 months
Other outcomes:
measure: Imaging changes
timeFrame: Baseline up to 12 months
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Carlos E. Vargas, M.D.
role: PRINCIPAL_INVESTIGATOR
References: