Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)

NCT ID: NCT04654975

Last Updated: 2024-07-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-02

Study Completion Date

2025-03-31

Brief Summary

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Esophagectomy is the cornerstone of the curative treatment of esophageal carcinoma. Despite this treatment, patients can suffer from locoregional or distant metastatic disease and only a very selected group of patients can be cured: mostly those with recurrence in one single organ.

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.

Detailed Description

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Conditions

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Esophageal Neoplasms Esophagectomy Brain Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients receiving surgical treatment for esophageal cancer between 1 januari 2000 and 31 december 2019
* All types of neoadjuvant treatment followed by surgery, primary surgery or salvage surgery.
* Adenocarcinoma or squamous cell carcinoma histology

Exclusion Criteria

* other histology type than adenocarcinoma or squamous cell carcinoma
* Hypopharyngeal carcinoma extending to the esophagus (requiring total laryngo-pharyngo-esophagectomy)
* Early esophageal carcinoma (cT IS-1a N0 M0)
* palliative esophagectomy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status NOT_YET_RECRUITING

Universitair ziekenhuis Gent

Ghent, , Belgium

Site Status NOT_YET_RECRUITING

Centre Hospitalier régional Universitaire de Lille

Lille, , France

Site Status NOT_YET_RECRUITING

Saint James Hospital

Dublin, , Ireland

Site Status NOT_YET_RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status RECRUITING

Zuyderland MC

Heerlen, , Netherlands

Site Status NOT_YET_RECRUITING

Erasmus MC

Rotterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Karolinska Institutet

Stockholm, , Sweden

Site Status RECRUITING

Countries

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United States Belgium France Ireland Netherlands Sweden

Central Contacts

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Lieven P Depypere, PhD

Role: CONTACT

+32 16 346820

Johnny Moons, Msc

Role: CONTACT

+32 16 346820

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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