The Role of Surgery for Esophageal Cancer With Metastatic Disease (M1)

May 20, 2024 updated by: National Taiwan University Hospital

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Zhongzheng
      • Taipei, Zhongzheng, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Stage IV Esophageal Cancer patients
  • Patients were treated with chemoradiation therapy (CCRT)

Exclusion Criteria:

  • Not Stage IV Esophageal Cancer patients
  • Patients were not treated with chemoradiation therapy (CCRT)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Jang-Ming Lee, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202211084RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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