- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07596654
The Impact of Surgical Treatment on Survival in Localized Small Cell Esophageal Cancer
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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Yi Shen, MD
- Número de telefone: +8613913907880
- E-mail: dryishen@nju.edu.cn
Estude backup de contato
- Nome: Zhuangzhuang Cong, PhD
- E-mail: czz061231007@126.com
Locais de estudo
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Jiangsu
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Nanjing, Jiangsu, China, 210002
- Recrutamento
- Jinling Hospital, Nanjing, Jiangsu Province, China.
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Contato:
- Zhuangzhuang Cong, PhD
- Número de telefone: +86 19962096499
- E-mail: czz061231007@126.com
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Investigador principal:
- Yi Shen, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Surgical treatment group
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Non-surgical treatment group
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Overall Survival
Prazo: From the date of diagnosis until death from any cause or last follow-up, assessed up to 5 years.
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From the date of diagnosis until death from any cause or last follow-up, assessed up to 5 years.
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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progression-free survival
Prazo: From the date of diagnosis until disease progression, death from any cause, or last follow-up, assessed up to 5 years.
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From the date of diagnosis until disease progression, death from any cause, or last follow-up, assessed up to 5 years.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025DZKY-023-02
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