Esophageal CancerNCT06424210
The Role of Surgery for Esophageal Cancer With Metastatic Disease (M1)
An observational study of Esophageal Cancer and Metastatic Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Treatment of stage IV esophageal cancer is traditionally palliative, but treatment response is usually poor. The role of surgery in the treatment of advanced esophageal cancer remains controversial. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Cancer, Metastatic Disease
- How many people
- 163 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2023to 1 Jun 2023
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: This study enrolled a cohort of patients diagnosed with stage IV esophageal cancer who had tumor metastasis to distant organs, including lymph node metastasis detected in the retroperitoneum, which could not be eradicated by surgery, from April 2002 to June 2021 in a tertiary medical center.
Who may be able to join
- Stage IV Esophageal Cancer patients
- Patients were treated with chemoradiation therapy (CCRT)
Who cannot join
- Not Stage IV Esophageal Cancer patients
- Patients were not treated with chemoradiation therapy (CCRT)
Trial locations and contacts
1 site in 1 country.
About this study
Treatment of stage IV esophageal cancer is traditionally palliative, but treatment response is usually poor. The role of surgery in the treatment of advanced esophageal cancer remains controversial. We sought to determine whether surgical treatment followed by neoadjuvant chemoradiation therapy might provide survival benefits for these patients.
A retrospective review of esophageal cancer patients with M1 disease treated at National Taiwan University Hospital was performed from April 2002 to June 2021. Patient demographics and cancer staging, treatment, and disease recurrence, and time of follow up were included for analysis. Univariate and multivariate analysis was performed for overall survival and progression-free survival analysis. Propensity score matching based on patient age and tumor staging characteristics was also performed for analysis.
- Conditions
- Esophageal Cancer, Metastatic Disease
- Medical subject headings
- Esophageal Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival and progression-free survival
Overall survival (OS) and progression-free survival (PFS) curves of patients with or without esophagectomy in the entire study cohort of stage IV esophageal cancer with distant metastasis.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start15 Feb 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jang-Ming Lee, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424210
- Sponsor's protocol ID
- 202211084RIND
- Status last verified
- Feb 2023
- First submitted
- 13 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Surgery for Esophageal Cancer With Metastatic Disease (M1)
- ClinicalTrials.gov ID
- NCT06424210
- Acronym / sponsor ID
- 202211084RIND
- Conditions
- Esophageal Cancer, Metastatic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 22 May 2024 (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.
Treatment of stage IV esophageal cancer is traditionally palliative, but treatment response is usually poor. The role of surgery in the treatment of advanced esophageal cancer remains controversial. We sought to determine whether surgical treatment followed by neoadjuvant chemoradiation therapy might provide survival benefits for these patients.
A retrospective review of esophageal cancer patients with M1 disease treated at National Taiwan University Hospital was performed from April 2002 to June 2021. Patient demographics and cancer staging, treatment, and disease recurrence, and time of follow up were included for analysis. Univariate and multivariate analysis was performed for overall survival and progression-free survival analysis. Propensity score matching based on patient age and tumor staging characteristics was also performed for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study enrolled a cohort of patients diagnosed with stage IV esophageal cancer who had tumor metastasis to distant organs, including lymph node metastasis detected in the retroperitoneum, which could not be eradicated by surgery, from April 2002 to June 2021 in a tertiary medical center.
Key inclusion criteria (2 listed)
- Stage IV Esophageal Cancer patients
- Patients were treated with chemoradiation therapy (CCRT)
Key exclusion criteria (2 listed)
- Not Stage IV Esophageal Cancer patients
- Patients were not treated with chemoradiation therapy (CCRT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival and progression-free survival
Time frame: 5 years
Overall survival (OS) and progression-free survival (PFS) curves of patients with or without esophagectomy in the entire study cohort of stage IV esophageal cancer with distant metastasis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
Jang-Ming Lee principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Metastatic Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival and progression-free survival (time frame: 5 years). 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 22 May 2024.