Clinical trial · Observational
Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
NCT04183218CI-TRIAL-00112633completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (56)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage I Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage II Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage III Esophageal Adenocarcinoma AJCC v8 | — | UNRESOLVED |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Cardiac Event Monitor | Device | — | UNRESOLVED |
| Chemoradiotherapy | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (cardiac monitoring)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Device: Cardiac Event Monitor
- Other: Chemoradiotherapy
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Proportion of Participants With a Cardiac Event at 12 Months
- timeFrame
- Up to 12 months
- description
- 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 outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.