Clinical trial NCT05996276: Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy (SATIATION)
Official title: Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophagus Cancer
Keywords: radiotherapy; cardiotoxicity
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-operated adult patients with localized or locally advanced esophageal cancer treated with radiochemotherapy or radiotherapy alone for curative purposes.

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.

Eligibility criteria: 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...)

Primary outcomes:
measure: Overall survival (OS)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The rate of cardiac events.
timeFrame: through study completion, an average of 1 year
measure: Response rate.
timeFrame: through study completion, an average of 1 year
measure: Progression-free survival (PFS).
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
affiliation: Radiation Oncology Department, Brest University Hospital
name: Vincent Bourbonne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: