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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophagus Cancer

Participation Criteria
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Eligibility Criteria
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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...)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS is defined as the time elapsed between inclusion and death, whatever the cause. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of cardiac events. | The rate of cardiac events. | through study completion, an average of 1 year | 
| Response rate. | Response rate. | through study completion, an average of 1 year | 
| Progression-free survival (PFS). | PFS 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. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy; cardiotoxicity