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

Recruiting

• Conditions: Esophagus Cancer

• Registration Number: NCT05996276
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-01
• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-18
• Primary Completion: 2023-09-30
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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...)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	through study completion, an average of 1 year	OS is defined as the time elapsed between inclusion and death, whatever the cause.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS).	through study completion, an average of 1 year	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.
The rate of cardiac events.	through study completion, an average of 1 year	The rate of cardiac events.
Response rate.	through study completion, an average of 1 year	Response rate.

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France