Esophageal NeoplasmsMETABRECNCT04654975
Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer (METABREC)
An observational study of Esophageal Neoplasms and Esophagectomy, run by Universitaire Ziekenhuizen KU Leuven at 8 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Neoplasms, Esophagectomy, Brain Metastases
- What is being tested?
- Esophagectomy for esophageal cancer
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 2 Jun 2020to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving surgical treatment for esophageal cancer between 1 januari 2000 and 31 december 2019
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Daan Voeten
Mark Van Berge Henegouwen, PhD
- Not yet recruiting
Zuyderland MC
Heerlen
Julie Van Den Bosch, MD
Meindert Sosef, PhD
- Not yet recruiting
Erasmus MC
Rotterdam
x gao
Bas Wijnhoven, PhD
United States1 site, 1 recruiting
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Patricia Abraham
Wayne Hofstetter
Belgium1 site, 1 recruiting
- Not yet recruiting
Universitair ziekenhuis Gent
Ghent
Inge Vandenbroucke
Elke Van Daele
France1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier régional Universitaire de Lille
Lille
Sébastien Degisors
Guillaume Piessen, PhD
Ireland1 site, 1 recruiting
- Not yet recruiting
Saint James Hospital
Dublin
Noel E Donlon
John Reynolds
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm
Biying Huang
Magnus Nilsson, PhD
About this study
Official title: Risk Factors and Treatment Options for Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer: a Multicentric Retrospective Cohort Study (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.
Read more
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
- Esophageal Neoplasms, Esophagectomy, Brain Metastases
- Being tested
- Esophagectomy for esophageal cancer
- Medical subject headings
- Esophageal Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagectomy for esophageal cancerProcedure or surgery
Surgical removal of (a part of) the esophagus and surgical reconstruction with another organ (mostly stomach, but may be colon or small bowel as well)
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds ratio (OR) for brain metastasis
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,…) .
Measured: 1 January 2000 - 1 March 2020
Secondary outcomes (5)
Overall survival
Overall survival after diagnosis of brain metastases stratified for treatment regimens applied.
Measured: 1 January 2000 - 1 March 2020
Time to recurrence
Time to recurrence, between incidence date of esophageal cancer and diagnosis of brainM+
Measured: 1 January 2000 - 1 March 2020
Risk factors for single site brain metastasis
such as different neoadjuvant treatment regimes, age, gender,and tumor factors (histology, stage, tumor differentiation,…)
Measured: 1 January 2000 - 1 March 2020
Number of brain metastases
Number of brain metastases
Measured: 1 January 2000 - 1 March 2020
Characteristics of brain metastases
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+
Measured: 1 January 2000 - 1 March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start2 Jun 2020
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieven P Depypere, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654975
- Sponsor's protocol ID
- S64060
- Acronym
- METABREC
- Status last verified
- Jul 2024
- First submitted
- 3 Dec 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Treatment Options for Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer: a Multicentric Retrospective Cohort Study (METABREC)
- ClinicalTrials.gov ID
- NCT04654975
- Acronym / sponsor ID
- METABREC / S64060
- Conditions
- Esophageal Neoplasms, Esophagectomy, Brain Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving surgical treatment for esophageal cancer between 1 januari 2000 and 31 december 2019
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophagectomy for esophageal cancerSurgical removal of (a part of) the esophagus and surgical reconstruction with another organ (mostly stomach, but may be colon or small bowel as well) | Procedure or surgery | – |
Primary outcome
Odds ratio (OR) for brain metastasis
Time frame: 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,…) .
5 secondary outcomes
Overall survival
Time frame: 1 January 2000 - 1 March 2020
Time to recurrence
Time frame: 1 January 2000 - 1 March 2020
Risk factors for single site brain metastasis
Time frame: 1 January 2000 - 1 March 2020
Number of brain metastases
Time frame: 1 January 2000 - 1 March 2020
Characteristics of brain metastases
Time frame: 1 January 2000 - 1 March 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieven P Depypere, PhD principal investigator
UZ Leuven
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasms and Esophagectomy, run by Universitaire Ziekenhuizen KU Leuven at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands, United States, Belgium, France, Ireland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lieven P Depypere, PhD (+32 16 346820, lieven.depypere@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds ratio (OR) for brain metastasis (time frame: 1 January 2000 - 1 March 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.