Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07596654

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Esophageal Carcinoma Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Limited-Stage Small Cell Esophageal Carcinoma Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jinling Hospital, Nanjing, Jiangsu Province, China.

Nanjing, Jiangsu, 210002, China

Location status: Recruiting

Location contact

Yi Shen, MD

PRINCIPAL_INVESTIGATOR

Zhuangzhuang Cong, PhD

CONTACT

[email protected]

+86 19962096499

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Shen, MD

CONTACT

[email protected]

+8613913907880

Zhuangzhuang Cong, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

yi shen

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.