Belgien Hospital started a clinical trial of Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer
The Universitaire Ziekenhuizen Leuven is conducting the clinical trial Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC) (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.
It is planned to include 10000 participants.
Actual study start date is June 2, 2020. The researchers expect to complete the study by March 31, 2021.
Among study population are patients receiving surgical treatment for esophageal cancer between 1 januari 2000 and 31 december 2019.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04654975) Houston, United States; Gent, Belgium; Lille, France; Dublin, Ireland; Amsterdam, Netherlands; Heerlen, Netherlands; Rotterdam, Netherlands; Stockholm, Sweden.
