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Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)

Risk Factors and Treatment Options for Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer: a Multicentric Retrospective Cohort Study (METABREC)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04654975
Acronym
METABREC
Enrollment
10000
Registered
2020-12-04
Start date
2020-06-02
Completion date
2025-03-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases, Esophageal Neoplasms, Esophagectomy

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.

Interventions

PROCEDUREEsophagectomy 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)

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Odds ratio (OR) for brain metastasis1 January 2000 - 1 March 2020Odds ratio (OR) for brain metastasis compared between primary surgery and neoadjuvant treatment plus surgery, OR for different neoadjuvant treatment regimes, corrected for gender and tumor factors (histology, stage, tumor differentiation,…) .

Secondary

MeasureTime frameDescription
Overall survival1 January 2000 - 1 March 2020Overall survival after diagnosis of brain metastases stratified for treatment regimens applied.
Time to recurrence1 January 2000 - 1 March 2020Time to recurrence, between incidence date of esophageal cancer and diagnosis of brainM+
Risk factors for single site brain metastasis1 January 2000 - 1 March 2020such as different neoadjuvant treatment regimes, age, gender,and tumor factors (histology, stage, tumor differentiation,…)
Number of brain metastases1 January 2000 - 1 March 2020Number of brain metastases
Characteristics of brain metastases1 January 2000 - 1 March 2020solitary/multiple; location /side in the brain; treatment) and the effects on 'OS after recurrence' (e.g. is there a significant survival benefit in patients with brainM+ if they are treated with brain-surgery and/or stereotactic radiotherapy compared to non-treated BrainM+ or palliative treatments of brainM+

Countries

Belgium, France, Ireland, Netherlands, Sweden, United States

Contacts

Primary ContactLieven P Depypere, PhD
lieven.depypere@uzleuven.be+32 16 346820
Backup ContactJohnny Moons, Msc
johnny.moons@uzleuven.be+32 16 346820

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026