NCT04654975 Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)
| NCT ID | NCT04654975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Esophageal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2020-06-02 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2020-06-02 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Lieven P Depypere, PhD
PRINCIPAL INVESTIGATOR
UZ Leuven
Frequently Asked Questions
Who can join the NCT04654975 clinical trial?
This trial is open to participants of all sexes, studying Esophageal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04654975 currently recruiting?
Yes, NCT04654975 is actively recruiting participants. Contact the research team at lieven.depypere@uzleuven.be for enrollment information.
Where is the NCT04654975 trial being conducted?
This trial is being conducted at Houston, United States, Ghent, Belgium, Lille, France, Dublin, Ireland and 4 additional locations.
Who is sponsoring the NCT04654975 clinical trial?
NCT04654975 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Lieven P Depypere, PhD at UZ Leuven. The trial plans to enroll 10,000 participants.