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

4. august 2026 opdateret af: yi shen

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.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Anslået)

4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210002
        • Rekruttering
        • Jinling Hospital, Nanjing, Jiangsu Province, China.
        • Kontakt:
        • Ledende efterforsker:
          • Yi Shen, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Surgical treatment group
Non-surgical treatment group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Overall Survival
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tidsramme
progression-free survival
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. maj 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

9. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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