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
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.
研究组 & 干预措施
Right thoracic approach
Neoadjuvant therapy+surgery+adjuvant therapy. Neoadjuvant therapy: chemotherapy with 2-4 cycles； Surgery: dissociate the stomach and operate the gastroesophagostomy and lower mediastinal lymphadenectomy by the right thoracic approach (right thoracic incision); Adjuvant therapy: perioperative chemotherapy with total 8 cycles (including neoadjuvant chemotherapy).
干预措施: different thoracic surgical approaches (Procedure)
Left thoracic approach
Neoadjuvant therapy+surgery+adjuvant therapy. Neoadjuvant therapy: chemotherapy with 2-4 cycles； Surgery: dissociate the stomach and operate the gastroesophagostomy and lower mediastinal lymphadenectomy by the left thoracic approach (including right thoracic and abdominal incision); Adjuvant therapy: perioperative chemotherapy with total 8 cycles (including neoadjuvant chemotherapy).
干预措施: different thoracic surgical approaches (Procedure)
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)