Skip to content

Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy (SATIATION)

Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05996276
Acronym
SATIATION
Enrollment
150
Registered
2023-08-18
Start date
2023-08-01
Completion date
2024-09-30
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Cancer

Keywords

radiotherapy; cardiotoxicity

Brief summary

Treatment of non-operable esophageal cancers is based on radiochemotherapy, or exclusive radiotherapy. The cardiac toxicity of radiotherapy in the treatment of thoracic tumor localizations is well documented, however, more and more studies are calling for the use of dosimetric parameters related to cardiac sub-structures to be integrated into clinical practice, rather than considering the heart as a whole. With this in mind, the aim of this study is to define the parameters, particularly dosimetric ones linked to cardiac sub-structures, influencing survival in patients treated with exclusive radiotherapy or radiochemotherapy for esophageal cancer.

Detailed description

Treatment of non-operable esophageal cancers is based on radiochemotherapy, or exclusive radiotherapy. The cardiac toxicity of radiotherapy in the treatment of thoracic tumor localizations is well documented, however, more and more studies are calling for the use of dosimetric parameters related to cardiac sub-structures to be integrated into clinical practice, rather than considering the heart as a whole. Although most of these data have been studied in populations with long-term follow-up, such as breast cancer, cardiac toxicity and the reduced survival it entails are also found in diseases such as esophageal cancer. With this in mind, the aim of this study is to define the parameters, particularly dosimetric ones linked to cardiac sub-structures, influencing survival in patients treated with exclusive radiotherapy or radiochemotherapy for esophageal cancer.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Histologically or cytologically proven esophageal cancer * Localized or locally advanced esophageal cancer treated with radiochemotherapy or exclusive radiotherapy * Tumor dose ≥ 50 Gy * Non-opposition of living patients formulated * Patient affiliated to a social security scheme

Exclusion criteria

* Age \< 18 years * Patient treated with upfront surgery * Tumor dose \< 50 Gy * Other concomitant neoplasia * Metastatic patient * Refusal to participate * Patient under legal protection (guardianship, curatorship, etc...)

Design outcomes

Primary

MeasureTime frameDescription
Overall survival (OS)through study completion, an average of 1 yearOS is defined as the time elapsed between inclusion and death, whatever the cause.

Secondary

MeasureTime frameDescription
The rate of cardiac events.through study completion, an average of 1 yearThe rate of cardiac events.
Response rate.through study completion, an average of 1 yearResponse rate.
Progression-free survival (PFS).through study completion, an average of 1 yearPFS is defined as the time elapsed between inclusion and tumor progression assessed by an expert panel according to RECIST v1.1 criteria, or death from any cause.

Countries

France

Contacts

Primary ContactVincent BOURBONNE, MD, PhD
vincent.bourbonne@chu-brest.fr+33298223398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026