Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)
NCT ID: NCT04654975
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2020-06-02
2025-03-31
Brief Summary
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Brain metastases are rare after esophagectomy for cancer, but they have a serious impact on survival. Agressive treatment is often moren difficult for brain metastases compared to other metastases and some risk factors have been identified earlier.
There is an impression that the incidence of brain metastases in esophageal cancer patients has increased since the introduction of neoadjuvant treatment schemes. However, this is not clear yet. A potential explanation could be that chemotherapy disturbs the blood-brain-barrier, hereby facilitating the migration of tumor cells to the brain.
The purpose of this study is to retrospectively analyze the incidence and potential risk factors of brain metastases in patients who underwent esophagectomy for esophageal cancer. Patients treated between 2000 and 2019 will be included and outcome parameters are Odds Ratio for brain metastases (comparison between primary surgery and neoadjuvant treatment followed by surgery), time to recurrence and risk factors, number and characteristics of the brain metastases.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Esophagectomy for esophageal cancer
Surgical removal of (a part of) the esophagus and surgical reconstruction with another organ (mostly stomach, but may be colon or small bowel as well)
Eligibility Criteria
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Inclusion Criteria
* All types of neoadjuvant treatment followed by surgery, primary surgery or salvage surgery.
* Adenocarcinoma or squamous cell carcinoma histology
Exclusion Criteria
* Hypopharyngeal carcinoma extending to the esophagus (requiring total laryngo-pharyngo-esophagectomy)
* Early esophageal carcinoma (cT IS-1a N0 M0)
* palliative esophagectomy
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Lieven P Depypere, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Universitair ziekenhuis Gent
Ghent, , Belgium
Centre Hospitalier régional Universitaire de Lille
Lille, , France
Saint James Hospital
Dublin, , Ireland
Amsterdam UMC
Amsterdam, , Netherlands
Zuyderland MC
Heerlen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Karolinska Institutet
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Patricia Abraham
Role: primary
Inge Vandenbroucke
Role: primary
Sébastien Degisors
Role: primary
Noel E Donlon
Role: primary
Daan Voeten
Role: primary
Julie Van Den Bosch, MD
Role: primary
x gao
Role: primary
Biying Huang
Role: primary
Other Identifiers
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S64060
Identifier Type: -
Identifier Source: org_study_id
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