N/A
Completed N=24
Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
Esophageal Cancer · Localized Lung Carcinoma · Stage 0 Lung Cancer AJCC v8 · Stage I Lung Cancer AJCC v8
Source: ClinicalTrials.gov NCT04183218 ↗
Enrolled (actual)
24
Serious AEs
16.7%
Results posted
Apr 2026
Primary outcomePrimary: Proportion of Participants With a Cardiac Event at 12 Months — 0.6818 proportion of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With a Cardiac Event at 12 Months |
0.6818 | — |
| SECONDARY Loco-regional Recurrence |
3 | — |
| SECONDARY Disease-free Survival |
0.832 | — |
| SECONDARY Distant Recurrence |
1 | — |
| SECONDARY Cardiac Event Free Survival |
.287 | — |
| SECONDARY Cardiac Death |
— | — |
| SECONDARY Overall Survival |
0.818 | — |
| SECONDARY Incidence of Acute 3+ Adverse Events (AE) |
3; 1; 3; 2; 1; 1 | — |
| SECONDARY Incidence of Late Grade 3+ Adverse Events |
6 | — |
| SECONDARY Cause Specific Survival |
1 | — |
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
Data sourced from ClinicalTrials.gov (NCT04183218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.