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