NCT06644352招募中不适用
A Prospective, Randomized, Controlled, Multicenter Study Comparing the Right Versus Left Thoracic Surgical Approaches for Locally Advanced Siewert II Gastroesophageal Junction Adenocarcinoma After Neoadjuvant Chemotherapy
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- OS rate
研究概览
简要总结
To explore the 5-year overall survival (OS) of right versus left thoracic surgical approaches for patients with locally advanced Siewert II gastroesophageal junction adenocarcinoma treated by neoadjuvant chemotherapy
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed gastroesophageal adenocarcinoma;
- •R0 resectable Siewert Ⅱ, cT2-3N0-3M0 (AJCC V8 TNM classification);
- •Have a performance status of 0 or 1 on the ECOG Performance Scale;
- •Age 18-80 years old, both men and women;
- •Estimated survival ≥6 months;
- •Be willing and able to provide written informed consent/assent for the trial;
- •Demonstrate adequate organ function ;
- •Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days before enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
- •Have not received systemic or local treatment for esophageal cancer in the past.
排除标准
- •Have a history of other malignant tumors in the past or at the same time;
- •Previous upper abdominal surgery (excluding cholecystectomy);
- •Bleeding, perforation and obstruction requiring emergency surgical treatment;
- •Severe heart, lung, liver and kidney dysfunction, which the researcher thinks is not suitable for operation;
- •Hydrothorax and ascites with clinical symptoms need therapeutic puncture or drainage;
- •Participate in other clinical studies or less than 1 month from the end of the previous clinical study;
- •Have a history of psychoactive drug abuse, alcoholism or drug abuse;
- •Be unable or do not agree to bear the inspection and treatment expenses at their own expense;
- •The researcher thinks that it should be excluded from this study.
结局指标
主要结局
OS rate
时间窗: 5 years
OS is defined as the time from randomization to death due to any cause.
次要结局
- DFS rate(3 years)
- pCR rate(1 month after resection)
- MPR rate(1 month after resection)
- Operative Complications(perioperative period)
研究者
研究点 (1)
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