Clinical trial NCT04654975: Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)
Official title: Risk Factors and Treatment Options for Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer: a Multicentric Retrospective Cohort Study (METABREC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Neoplasms
Esophagectomy
Brain Metastases
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving surgical treatment for esophageal cancer between 1 januari 2000 and 31 december 2019

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Odds ratio (OR) for brain metastasis
timeFrame: 1 January 2000 - 1 March 2020
Secondary outcomes:
measure: Overall survival
timeFrame: 1 January 2000 - 1 March 2020
measure: Time to recurrence
timeFrame: 1 January 2000 - 1 March 2020
measure: Risk factors for single site brain metastasis
timeFrame: 1 January 2000 - 1 March 2020
measure: Number of brain metastases
timeFrame: 1 January 2000 - 1 March 2020
measure: Characteristics of brain metastases
timeFrame: 1 January 2000 - 1 March 2020
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Gent
country: Belgium
facility: Universitair ziekenhuis Gent
city: Lille
country: France
facility: Centre Hospitalier régional Universitaire de Lille
city: Dublin
country: Ireland
facility: Saint James Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Heerlen
country: Netherlands
facility: Zuyderland MC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: UZ Leuven
name: Lieven P Depypere, PhD
role: PRINCIPAL_INVESTIGATOR
References: