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临床试验/NCT06364566
NCT06364566已完成不适用

Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2010年10月15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
303
试验地点
1
主要终点
The Disease-Free survival of the overall population

研究概览

简要总结

The optimal interval between neoadjuvant chemradiotherapy and esophagectomy is still a question that needs to be explored for patients with esophageal squamous cell carcinoma. In this study, based on previous studies, the investigators divided patients into two groups with a cutoff value of 50 days. By comparing the overall survival and disease-free survival of the entire population and non PCR population, the investigators ultimately obtained the optimal surgical timing suitable for clinical use

详细描述

background:Neoadjuvant chemoradiotherapy has gradually become a first-line treatment for esophageal squamous cell carcinoma patients. After the completion of neoadjuvant chemoradiotherapy, patients usually undergo minimally invasive surgery to ensure complete removal of the tumor and lymphatic tissue. However, the optimal interval between neoadjuvant chemoradiotherapy and minimally invasive surgery is still an unknown factor, and whether it affects postoperative disease-free survival (DFS) and overall survival (OS) of patients remains unknown. Therefore, the main purpose of this study is to explore the specific impact of the interval between neoadjuvant chemoradiotherapy and minimally invasive surgery on patients, and to find the optimal interval time.

methods:Patients who underwent neoadjuvant chemoradiotherapy and minimally invasive surgery from two institutions between October 2010 and September 2019 were included in this study. The time interval is defined as the days between the last time a patient receives neoadjuvant chemoradiotherapy and the execution of surgery. Based on past research, the interval between the two groups was determined to be 50 days. The main research result is the OS and DFS of different interval groups in the overall population and non-PCR population. A multivariate Cox regression model was established to determine the main factors affecting Patient's OS and DFS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • (I) thoracic ESCC
  • (II) no history of concomitant or prior malignancy
  • (III) Completed one cycle of nCRT
  • (IV) Received endoscopic radical surgery for esophageal cancer

排除标准

  • (I)other histological subtypes
  • (II)Received ESD treatment
  • (III) Radiation dose greater than 50Gy
  • (IV) Metastatic esophageal squamous cell carcinoma

结局指标

主要结局

The Disease-Free survival of the overall population

时间窗: 5 years

Is there any tumor metastasis or recurrence in the overall population

The overall survival of the overall population

时间窗: 5 years

Does the overall population survive

The Disease-Free survival of the PCR population

时间窗: 5 years

Is there any tumor metastasis or recurrence in the PCR population

The overall survival of the non-PCR population

时间窗: 5 years

Does the non-PCR population survive

The Disease-Free survival of the non-PCR population

时间窗: 5 years

Is there any tumor metastasis or recurrence in the non-PCR population

The overall survival of the PCR population

时间窗: 5 years

Does the PCR population survive

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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