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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Overall Survival [Срок оценки: From the date of diagnosis until death from any cause or last follow-up, assessed up to 5 years.]

Вторичные конечные точки (1)

• progression-free survival [Срок оценки: From the date of diagnosis until disease progression, death from any cause, or last follow-up, assessed up to 5 years.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Jinling Hospital, Nanjing, Jiangsu Province, China. — Нанкин

Идентификаторы

NCT: NCT07596654 · 2025DZKY-023-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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