The Impact of Surgical Treatment on Survival in Localized Small Cell Esophageal Cancer

August 4, 2026 updated by: yi shen

The Impact of Surgical Versus Non-surgical Treatment on Survival in Localized Esophageal Small Cell Carcinoma: a Single-center Retrospective Cohort Study

Limited-stage small cell esophageal carcinoma (LS-SCEC) is a rare and highly aggressive malignancy with poor prognosis and no established standard treatment strategy. Due to its low incidence, current evidence is mainly derived from small retrospective studies, and the role of surgery in multimodal treatment remains controversial. In particular, the survival benefit of surgical treatment compared with definitive non-surgical therapy has not been fully clarified.

This single-center retrospective cohort study aims to evaluate the impact of surgical versus non-surgical treatment strategies on survival outcomes in patients with LS-SCEC. Patients receiving surgical treatment, including surgery alone, neoadjuvant therapy followed by surgery, or surgery followed by adjuvant therapy, will be compared with patients receiving definitive non-surgical treatment, including chemoradiotherapy-based approaches.

Clinical characteristics, treatment patterns, and survival outcomes will be retrospectively collected and analyzed. The primary endpoint is overall survival (OS). Secondary endpoints include progression-free survival (PFS) and treatment-related prognostic factors. Propensity score-based methods and multivariable survival analyses will be performed to reduce potential selection bias and evaluate the independent association between treatment strategy and prognosis.

The study is expected to provide additional real-world evidence regarding the optimal management of LS-SCEC and help guide individualized treatment decision-making for this rare disease.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

4

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • Jinling Hospital, Nanjing, Jiangsu Province, China.
        • Contact:
        • Principal Investigator:
          • Yi Shen, MD

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

No

Sampling Method

Non-Probability Sample

Study Population

Patients pathologically diagnosed with limited-stage small cell esophageal carcinoma (LS-SCEC) who received treatment at Jinling Hospital during the study period will be retrospectively identified from institutional medical records. Eligible patients will include those who underwent surgical treatment (with or without neoadjuvant or adjuvant therapy) as well as those who received definitive non-surgical treatment, including chemoradiotherapy-based approaches. Clinical characteristics, treatment information, and follow-up data will be collected for survival analysis.

Description

Inclusion Criteria:

  • Patients pathologically diagnosed with primary small cell esophageal carcinoma (SCEC).
  • Patients classified as having limited-stage disease at initial diagnosis, defined as tumor confined to the esophagus and/or regional lymph nodes without evidence of distant metastasis.
  • Patients who received definitive treatment at the study institution, including surgical treatment (with or without neoadjuvant or adjuvant therapy) or definitive non-surgical treatment such as chemoradiotherapy-based therapy.
  • Patients with complete baseline clinicopathological and treatment information available in the medical records.
  • Patients with available follow-up and survival outcome data.

Exclusion Criteria:

  • Patients with extensive-stage disease or distant metastasis at diagnosis.
  • Patients with mixed histological subtypes in which small cell carcinoma was not the predominant component.
  • Patients who received palliative treatment only.
  • Patients with a history of other active malignant tumors within the previous 5 years.
  • Patients with incomplete key clinical, treatment, or follow-up data.
  • Patients under 18 years old.

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

Cohorts and Interventions

Group / Cohort
Surgical treatment group
Non-surgical treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From the date of diagnosis until death from any cause or last follow-up, assessed up to 5 years.
From the date of diagnosis until death from any cause or last follow-up, assessed up to 5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: From the date of diagnosis until disease progression, death from any cause, or last follow-up, assessed up to 5 years.
From the date of diagnosis until disease progression, death from any cause, or last follow-up, assessed up to 5 years.

Collaborators and Investigators

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

Sponsor

yi shen

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)

May 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 9, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025DZKY-023-02

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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