Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients receiving surgical treatment for esophageal cancer between 1 januari 2000 and 31 december 2019
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Esophagectomy for esophageal cancer
Procedure/SurgerySurgical removal of (a part of) the esophagus and surgical reconstruction with another organ (mostly stomach, but may be colon or small bowel as well)
Treatment groups
No treatment groups listed
Trial outcomes
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,…) .
Time frame
1 January 2000 - 1 March 2020Secondary outcomes
1
Overall survival
Overall survival after diagnosis of brain metastases stratified for treatment regimens applied.
Time frame
1 January 2000 - 1 March 20202
Time to recurrence
Time to recurrence, between incidence date of esophageal cancer and diagnosis of brainM+
Time frame
1 January 2000 - 1 March 20203
Risk factors for single site brain metastasis
such as different neoadjuvant treatment regimes, age, gender,and tumor factors (histology, stage, tumor differentiation,…)
Time frame
1 January 2000 - 1 March 20204
Number of brain metastases
Number of brain metastases
Time frame
1 January 2000 - 1 March 2020Sponsors and contacts
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Source ClinicalTrials.gov