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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Yi Shen, MD
- Numero di telefono: +8613913907880
- Email: dryishen@nju.edu.cn
Backup dei contatti dello studio
- Nome: Zhuangzhuang Cong, PhD
- Email: czz061231007@126.com
Luoghi di studio
-
-
Jiangsu
-
Nanjing, Jiangsu, Cina, 210002
- Reclutamento
- Jinling Hospital, Nanjing, Jiangsu Province, China.
-
Contatto:
- Zhuangzhuang Cong, PhD
- Numero di telefono: +86 19962096499
- Email: czz061231007@126.com
-
Investigatore principale:
- Yi Shen, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Surgical treatment group
|
|
Non-surgical treatment group
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Overall Survival
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
progression-free survival
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025DZKY-023-02
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .