Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)

Brain Metastases Clinical Trial

— METABREC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654975
• Other study ID #: S64060
• Status: Recruiting
• Start date: June 2, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: December 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Lieven P Depypere, PhD
• Phone: +32 16 346820
• Email: lieven.depypere[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Esophageal Neoplasms
• Esophagectomy
• Neoplasm Metastasis

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Belgium	Universitair ziekenhuis Gent	Gent
France	Centre Hospitalier régional Universitaire de Lille	Lille
Ireland	Saint James Hospital	Dublin
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Zuyderland MC	Heerlen
Netherlands	Erasmus MC	Rotterdam
Sweden	Karolinska Institutet	Stockholm
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Odds ratio (OR) for brain metastasis	Odds 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,…) .	1 January 2000 - 1 March 2020
Secondary	Overall survival	Overall survival after diagnosis of brain metastases stratified for treatment regimens applied.	1 January 2000 - 1 March 2020
Secondary	Time to recurrence	Time to recurrence, between incidence date of esophageal cancer and diagnosis of brainM+	1 January 2000 - 1 March 2020
Secondary	Risk factors for single site brain metastasis	such as different neoadjuvant treatment regimes, age, gender,and tumor factors (histology, stage, tumor differentiation,…)	1 January 2000 - 1 March 2020
Secondary	Number of brain metastases	Number of brain metastases	1 January 2000 - 1 March 2020
Secondary	Characteristics of brain metastases	solitary/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+	1 January 2000 - 1 March 2020