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临床试验/NCT04764240
NCT04764240已完成不适用

Prognostic Value of Examined and Metastatic Lymph Nodes in Chinese Esophageal Squamous Cell Carcinoma Patients Received Lymphadenectomy

Shanghai Cancer Hospital, China0 个研究点目标入组 3,700 人开始时间: 2003年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,700
主要终点
OS

研究概览

简要总结

Data were collected on a large multi-institution dataset consisting of ESCC patients who underwent surgery between January 2003 and December 2013 at ten institutions in the People's Republic of China. The datasets were approved for research by the institutional review board of each participating center. Prior to surgery, all patients received computerised tomography (CT) of the chest and abdomen and EUS as part of their routine staging workup. Patients received whole body FDG-PET to eliminate the possibility of distant metastases if the attending physician considered it was necessary. All patients in the dataset received a surgical R0 resection; patients who received an R1 or R2 resection were excluded. Notably, there is nothing approaching a consensus on the extent of lymph node dissection for ESCC patients. Patients who received neoadjuvant therapy were excluded due to the influence of neoadjuvant therapy on lymph node status and pathologic T stage. The primary endpoints were overall survival (OS), which was defined as the time between surgical resection and death from any cause, and cancer-specific survival (CSS), defined as the time from surgical resection to death caused by ESCC. After receiving esophagectomy, patients were followed up by clinical examination every three months for the first year, every three to six months for the second year, and every six to twelve months from then on.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Minimum age: 18 years
  • Patients underwent R0 resection and lymphadenectomy.
  • ECOG PS less than or equal 2
  • Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count > 1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl
  • Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT < 3 x ULN
  • Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min
  • Written informed consent before randomization

排除标准

  • R1 or R2 resection
  • Patients underwent neoadjuvant therapy
  • Fertile patients without adequate contraception during therapy
  • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:* Central nervous system disorders or psychiatric disability including dementia or epileptic disease; * active uncontrolled intercurrent infections or sepsis
  • Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator

结局指标

主要结局

OS

时间窗: Five years

Overall survival

次要结局

未报告次要终点

研究者

发起方
Shanghai Cancer Hospital, China
申办方类型
Other
责任方
Sponsor

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