Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8NCT04183218
Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
An observational study of Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8 and Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8, Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage I Esophageal Adenocarcinoma AJCC v8
- What is being tested?
- Biospecimen Collection, Cardiac Event Monitor and Chemoradiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 2 May 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-metastatic, non-recurrent lung and esophageal cancer patients who are receiving thoracic radiotherapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer.
EXPLORATORY OBJECTIVES:
- 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.
- 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.
- 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
- Being tested
- Biospecimen Collection, Cardiac Event Monitor, Chemoradiotherapy, Radiation Therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo biospecimen collection
Cardiac Event MonitorDevice
Receive cardiac monitor
ChemoradiotherapyOther
Also called Chemoradiation, CRT, CRTx, Radiochemotherapy
Undergo CRT
Radiation TherapyRadiation
Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated
Undergo RT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Device: Cardiac Event Monitor; Other: Chemoradiotherapy; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (9)
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.
Measured: Up to 12 months
Disease-free Survival
Disease- free survival is defined as the time from study registration until any disease recurrence or death.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Overall Survival
Overall survival is defined as the time from registration to death due to any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start23 Sep 2019
- Primary completion6 Jan 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos E. Vargas, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183218
- Sponsor's protocol ID
- MC1723
- Other IDs
- NCI-2019-07938, MC1723, 17-008401
- Status last verified
- Aug 2024
- First submitted
- 27 Nov 2019
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No