Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)

NCT04654975 | Recruiting

• 1 other identifier: S64060
• Study Type: observational
• Target: 10,000
• Locations: 6 countries
• Sites: 8

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.

Conditions

Esophageal Neoplasms; Esophagectomy; Brain Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall survival

  1 January 2000 - 1 March 2020

• Time to recurrence

  1 January 2000 - 1 March 2020

• Risk factors for single site brain metastasis

  1 January 2000 - 1 March 2020

• Number of brain metastases

  1 January 2000 - 1 March 2020

• Characteristics of brain metastases

  1 January 2000 - 1 March 2020

Interventions

Esophagectomy for esophageal cancer PROCEDURE

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

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving surgical treatment for esophageal cancer between 1 januari 2000 and 31 december 2019

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (8)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Universitair ziekenhuis Gent

Ghent, Belgium

NOT YET RECRUITING

Centre Hospitalier régional Universitaire de Lille

Lille, France

NOT YET RECRUITING

Saint James Hospital

Dublin, Ireland

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Zuyderland MC

Heerlen, Netherlands

NOT YET RECRUITING

Erasmus MC

Rotterdam, Netherlands

NOT YET RECRUITING

Karolinska Institutet

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Brain Neoplasms

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Lieven P Depypere, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieven P Depypere, PhD

CONTACT

+32 16 346820; lieven.depypere@uzleuven.be

Johnny Moons, Msc

CONTACT

+32 16 346820; johnny.moons@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 4, 2020
• Study Start: June 2, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

US (1); NL (3); BE (1); FR (1); IE (1); SE (1)