Precisely Estimation of the Prognostic Value of Lymph Node in ESCC
2021年2月19日 更新者:Shanghai Cancer Hospital, China
Prognostic Value of Examined and Metastatic Lymph Nodes in Chinese Esophageal Squamous Cell Carcinoma Patients Received Lymphadenectomy
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.
研究概览
研究类型
观察性的
注册 (实际的)
3700
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients elder than 18 years old 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.
Patients underwent R0 resection and lymphadenectomy.
描述
Inclusion Criteria:
- 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 7. Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min
- Written informed consent before randomization
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
OS
大体时间:Five years
|
Overall survival
|
Five years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2003年1月1日
初级完成 (实际的)
2013年12月30日
研究完成 (实际的)
2018年12月1日
研究注册日期
首次提交
2021年2月18日
首先提交符合 QC 标准的
2021年2月19日
首次发布 (实际的)
2021年2月21日
研究记录更新
最后更新发布 (实际的)
2021年2月23日
上次提交的符合 QC 标准的更新
2021年2月19日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.