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Trial Title:
Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy (SATIATION)
NCT ID:
NCT05996276
Condition:
Esophagus Cancer
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
radiotherapy; cardiotoxicity
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
Non-operated adult patients with localized or locally advanced esophageal cancer treated
with radiochemotherapy or radiotherapy alone for curative purposes.
Sampling method:
Non-Probability Sample
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...)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chu Brest
Address:
City:
Brest
Zip:
29609
Country:
France
Status:
Recruiting
Contact:
Last name:
Vincent Bourbonne, MD, PhD
Phone:
+33298223398
Email:
vincent.bourbonne@chu-brest.fr
Start date:
August 1, 2023
Completion date:
September 30, 2024
Lead sponsor:
Agency:
University Hospital, Brest
Agency class:
Other
Source:
University Hospital, Brest
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05996276
