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NCT Number: NCT04654975

Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Odds ratio (OR) for brain metastasis

    Time frame: 1 January 2000 - 1 March 2020

    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,…) .

Secondary outcomes

  1. Overall survival

    Time frame: 1 January 2000 - 1 March 2020

    Overall survival after diagnosis of brain metastases stratified for treatment regimens applied.

  2. Time to recurrence

    Time frame: 1 January 2000 - 1 March 2020

    Time to recurrence, between incidence date of esophageal cancer and diagnosis of brainM+

  3. Risk factors for single site brain metastasis

    Time frame: 1 January 2000 - 1 March 2020

    such as different neoadjuvant treatment regimes, age, gender,and tumor factors (histology, stage, tumor differentiation,…)

  4. Number of brain metastases

    Time frame: 1 January 2000 - 1 March 2020

    Number of brain metastases

  5. Characteristics of brain metastases

    Time frame: 1 January 2000 - 1 March 2020

    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+

Study contacts

Contact information is provided by the study sponsor or research team.

Johnny Moons, Msc

CONTACT

[email protected]

+32 16 346820

Lieven P Depypere, PhD

CONTACT

[email protected]

+32 16 346820

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: METABREC

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2020
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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