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NCT04654975 · ClinicalTrials.gov registry record
Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)
A clinical trial of Brain Metastases and Esophageal Neoplasms, sponsored by Universitaire Ziekenhuizen KU Leuven.
- Recruiting
- Registry status
- 10,000
- Enrollment target
- 8
- Study locations
NCT04654975 is a study of Brain Metastases and Esophageal Neoplasms that is actively recruiting participants, run by Universitaire Ziekenhuizen KU Leuven. The registered enrollment target is 10,000 participants, above the 64-participant average among 67 other Brain Metastases trials with a reported enrollment target (15525% higher). The trial reports 8 study locations across 2 states.
The verdict
NCT04654975, a study of Brain Metastases and Esophageal Neoplasms, is actively recruiting participants, sponsored by Universitaire Ziekenhuizen KU Leuven.
- RECRUITING
- Registry status
- 10,000 participants
- Enrollment target
- 8
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Esophagectomy for esophageal cancer
Study Locations (8)
Other
- Universitair ziekenhuis Gent - Ghent
- Centre Hospitalier régional Universitaire de Lille - Lille
- Saint James Hospital - Dublin
- Amsterdam UMC - Amsterdam
- Zuyderland MC - Heerlen
- Erasmus MC - Rotterdam
- Karolinska Institutet - Stockholm
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,000 participants |
| Start Date | 2020-06-02 |
| Est. Completion | 2025-03-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04654975
The ClinicalTrials.gov registry entry for NCT04654975 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 10,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 64-participant average among 67 other Brain Metastases trials with a reported enrollment target (15525% higher). The listed sponsor is Universitaire Ziekenhuizen KU Leuven, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Brain Metastases appearing as the primary indexed condition, and to 1 intervention - of which Esophagectomy for esophageal cancer is the first listed.
NCT04654975 reports 8 study locations spanning 2 distinct geographic areas - top geographies include Other, Texas.
Frequently Asked Questions
What is clinical trial NCT04654975 about?
NCT04654975 is a clinical study titled "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...
What is the current status of trial NCT04654975?
This trial is currently recruiting. The enrollment target is 10,000 participants. The study started on 2020-06-02. Estimated completion is 2025-03-31.
What conditions does trial NCT04654975 study?
This clinical trial studies the following conditions: Brain Metastases, Esophageal Neoplasms, Esophagectomy.
What interventions are being tested in trial NCT04654975?
The interventions under investigation include: Esophagectomy for esophageal cancer (PROCEDURE).
Who is sponsoring clinical trial NCT04654975?
This trial is sponsored by Universitaire Ziekenhuizen KU Leuven, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04654975 being conducted?
This trial has 8 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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