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

NCT07596654 | Recruiting DMC

• 1 other identifier: 2025DZKY-023-02
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Limited-Stage Small Cell Esophageal Carcinoma; Esophageal Carcinoma

Keywords

Small Cell Esophageal Carcinoma; Limited-Stage Esophageal Small Cell Carcinoma; Surgery; Chemoradiotherapy; Survival; Prognosis; Retrospective Cohort Study

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From the date of diagnosis until death from any cause or last follow-up, assessed up to 5 years.

Secondary Outcomes (1)

• progression-free survival

  From the date of diagnosis until disease progression, death from any cause, or last follow-up, assessed up to 5 years.

Study Arms (2)

Surgical treatment group

Non-surgical treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• yi shen: lead

Study Sites (1)

Jinling Hospital, Nanjing, Jiangsu Province, China.

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Yi Shen, MD

CONTACT

+8613913907880; dryishen@nju.edu.cn

Zhuangzhuang Cong, PhD

CONTACT

czz061231007@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 19, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

CN (1)