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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Yi Shen, MD
- 전화번호: +8613913907880
- 이메일: dryishen@nju.edu.cn
연구 연락처 백업
- 이름: Zhuangzhuang Cong, PhD
- 이메일: czz061231007@126.com
연구 장소
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Jiangsu
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Nanjing, Jiangsu, 중국, 210002
- 모병
- Jinling Hospital, Nanjing, Jiangsu Province, China.
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연락하다:
- Zhuangzhuang Cong, PhD
- 전화번호: +86 19962096499
- 이메일: czz061231007@126.com
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수석 연구원:
- Yi Shen, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Surgical treatment group
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Non-surgical treatment group
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Overall Survival
기간: 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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2차 결과 측정
결과 측정 |
기간 |
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progression-free survival
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .