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

NCT05996276 | Unknown

• 1 other identifier: 29BRC23.0144 - SATIATION
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagus Cancer

Keywords

radiotherapy; cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The rate of cardiac events.

  through study completion, an average of 1 year

• Response rate.

  through study completion, an average of 1 year

• Progression-free survival (PFS).

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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...)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Vincent Bourbonne, MD, PhD

  Radiation Oncology Department, Brest University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent BOURBONNE, MD, PhD

CONTACT

+33298223398; vincent.bourbonne@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 18, 2023
• Study Start: August 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)