Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)
- Conditions
- Esophageal NeoplasmsEsophagectomyBrain Metastases
- Registration Number
- NCT04654975
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Odds ratio (OR) for brain metastasis 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 Outcome Measures
Name Time Method Number of brain metastases 1 January 2000 - 1 March 2020 Number of brain metastases
Overall survival 1 January 2000 - 1 March 2020 Overall survival after diagnosis of brain metastases stratified for treatment regimens applied.
Time to recurrence 1 January 2000 - 1 March 2020 Time to recurrence, between incidence date of esophageal cancer and diagnosis of brainM+
Characteristics of brain metastases 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+
Risk factors for single site brain metastasis 1 January 2000 - 1 March 2020 such as different neoadjuvant treatment regimes, age, gender,and tumor factors (histology, stage, tumor differentiation,...)
Trial Locations
- Locations (8)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Saint James Hospital
🇮🇪Dublin, Ireland
Zuyderland MC
🇳🇱Heerlen, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands
Amsterdam UMC
🇳🇱Amsterdam, Netherlands
Universitair ziekenhuis Gent
🇧🇪Gent, Belgium
Karolinska Institutet
🇸🇪Stockholm, Sweden
Centre Hospitalier régional Universitaire de Lille
🇫🇷Lille, France