NCT06424210

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
Last Updated

May 22, 2024

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

May 13, 2024

Last Update Submit

May 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng, 100, Taiwan

Location

MeSH Terms

Conditions

Esophageal NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jang-Ming Lee

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 22, 2024

Study Start

February 15, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

May 22, 2024

Record last verified: 2023-02

Locations