Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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+
- 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,…)
- Number of brain metastases [1 January 2000 - 1 March 2020]
Number of brain metastases
- 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+
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients receiving surgical treatment for esophageal cancer between 1 januari 2000 and 31 december 2019
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All types of neoadjuvant treatment followed by surgery, primary surgery or salvage surgery.
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Adenocarcinoma or squamous cell carcinoma histology
Exclusion Criteria:
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other histology type than adenocarcinoma or squamous cell carcinoma
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Hypopharyngeal carcinoma extending to the esophagus (requiring total laryngo-pharyngo-esophagectomy)
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Early esophageal carcinoma (cT IS-1a N0 M0)
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palliative esophagectomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 2 | Universitair ziekenhuis Gent | Gent | Belgium | ||
| 3 | Centre Hospitalier régional Universitaire de Lille | Lille | France | ||
| 4 | Saint James Hospital | Dublin | Ireland | ||
| 5 | Amsterdam UMC | Amsterdam | Netherlands | ||
| 6 | Zuyderland MC | Heerlen | Netherlands | ||
| 7 | Erasmus MC | Rotterdam | Netherlands | ||
| 8 | Karolinska Institutet | Stockholm | Sweden |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
Investigators
- Principal Investigator: Lieven P Depypere, PhD, UZ Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S64060