NCT04183218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2024

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 21, 2026

Completed
Last Updated

April 21, 2026

Status Verified

August 1, 2024

Enrollment Period

4.3 years

First QC Date

November 27, 2019

Results QC Date

January 26, 2026

Last Update Submit

March 30, 2026

Conditions

Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8Clinical Stage I Esophageal Adenocarcinoma AJCC v8Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8Localized Esophageal CarcinomaLocalized Lung CarcinomaPathologic Stage 0 Esophageal Adenocarcinoma AJCC v8Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage I Esophageal Adenocarcinoma AJCC v8Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage III Esophageal Adenocarcinoma AJCC v8Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage I Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8Stage 0 Lung Cancer AJCC v8Stage I Lung Cancer AJCC v8Stage IA1 Lung Cancer AJCC v8Stage IA2 Lung Cancer AJCC v8Stage IA3 Lung Cancer AJCC v8Stage IB Lung Cancer AJCC v8Stage II Lung Cancer AJCC v8Stage IIA Lung Cancer AJCC v8Stage IIB Lung Cancer AJCC v8Stage III Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage I Esophageal Squamous Cell Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Loco-regional Recurrence

    Up to 12 months

  • Disease-free Survival

    Up to 12 months

  • Distant Recurrence

    Up to 12 months

  • Cardiac Event Free Survival

    Up to 12 months

  • Cardiac Death

    Up to 12 months

  • +4 more secondary outcomes

Other Outcomes (1)

  • Imaging Changes

    Baseline up to 12 months

Study Arms (1)

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 CollectionDevice: Cardiac Event MonitorOther: ChemoradiotherapyRadiation: Radiation Therapy

Interventions

Biospecimen CollectionPROCEDURE

Undergo biospecimen collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Observational (cardiac monitoring)
Cardiac Event MonitorDEVICE

Receive cardiac monitor

Observational (cardiac monitoring)
ChemoradiotherapyOTHER

Undergo CRT

Also known as: Chemoradiation, CRT, CRTx, Radiochemotherapy, RCTx, RT-CT
Observational (cardiac monitoring)
Radiation TherapyRADIATION

Undergo RT

Also known as: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Observational (cardiac monitoring)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Non-metastatic, non-recurrent lung and esophageal cancer patients who are receiving thoracic radiotherapy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Specimen HandlingChemoradiotherapyRadiotherapyRadiation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesCombined Modality TherapyTherapeuticsDrug TherapyPhysical Phenomena

Results Point of Contact

Title
Dr. Carlos E. Vargas
Organization
Mayo Clinic
vargas.carlos@mayo.edu
480-342-1262

Study Officials

  • Carlos E. Vargas, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 3, 2019

Study Start

September 23, 2019

Primary Completion

January 6, 2024

Study Completion

May 2, 2024

Last Updated

April 21, 2026

Results First Posted

April 21, 2026

Record last verified: 2024-08

Locations

US(1)