Esophagus CancerSATIATIONNCT05996276
Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy (SATIATION)
An observational study of Esophagus Cancer, run by University Hospital, Brest at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-operated adult patients with localized or locally advanced esophageal cancer treated with radiochemotherapy or radiotherapy alone for curative purposes.
Who may be able to join
- 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
Who cannot join
- 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...)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Brest
Brest, 29609
Vincent Bourbonne, MD, PhD, +33298223398, vincent.bourbonne@chu-brest.fr
About this study
Official title: Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy
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.
Read the 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.
- Conditions
- Esophagus Cancer
- Keywords
- radiotherapy; cardiotoxicity
- Medical subject headings
- Esophageal Neoplasms, Cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS is defined as the time elapsed between inclusion and death, whatever the cause.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
The rate of cardiac events.
The rate of cardiac events.
Measured: through study completion, an average of 1 year
Response rate.
Response rate.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Aug 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Bourbonne, MD, PhD, Principal investigator, Radiation Oncology Department, Brest University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996276
- Sponsor's protocol ID
- 29BRC23.0144 - SATIATION
- Acronym
- SATIATION
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05996276
- Acronym / sponsor ID
- SATIATION / 29BRC23.0144 - SATIATION
- Conditions
- Esophagus Cancer
- Keywords
- radiotherapy; cardiotoxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-operated adult patients with localized or locally advanced esophageal cancer treated with radiochemotherapy or radiotherapy alone for curative purposes.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Age < 18 years
- Patient treated with upfront surgery
- Tumor dose < 50 Gy
- Other concomitant neoplasia
- Metastatic patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: through study completion, an average of 1 year
OS is defined as the time elapsed between inclusion and death, whatever the cause.
3 secondary outcomes
The rate of cardiac events.
Time frame: through study completion, an average of 1 year
Response rate.
Time frame: through study completion, an average of 1 year
Progression-free survival (PFS).
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Bourbonne, MD, PhD principal investigator
Radiation Oncology Department, Brest University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagus Cancer, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent BOURBONNE, MD, PhD (+33298223398, vincent.bourbonne@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.