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

Esophagus Cancer Clinical Trial

— SATIATION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996276
• Other study ID #: 29BRC23.0144 - SATIATION
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Brest
• Contact: Vincent BOURBONNE, MD, PhD
• Phone: +33298223398
• Email: vincent.bourbonne[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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...)

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Locations

Country	Name	City	State
France	Chu Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The rate of cardiac events.	The rate of cardiac events.	through study completion, an average of 1 year
Secondary	Response rate.	Response rate.	through study completion, an average of 1 year
Secondary	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