A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Investigation the Value of Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 508
- 试验地点
- 13
- 主要终点
- Overall survival
研究概览
简要总结
The investigators study aims to explore the potential function of extensive intraoperative peritoneal lavage in improving the overall survival and progression-free survival for locally advanced gastric cancer after curative resection.
Hypothesis: Overall survival and progression-free survival of locally advanced gastric cancer are improved by extensive intraoperative peritoneal lavage.
详细描述
Gastric cancer has been one of the most frequently common cancers and remains the third leading cause of death among malignant tumors all over the world. Surgery has always been considered as the most effective treatment. While significant surgical technique and perioperative management have dramatically improved the survival of patients with advanced gastric cancer, patients with T4 stage or serosal-positive gastric cancer often suffer from recurrence as peritoneal dissemination, and the prognosis of those patients is extremely poor. Despite curatively resected, Peritoneal metastasis is completed by the implantation of peritoneal free cancer cells exfoliated from serosa-invasive tumors. Therefore, things need to be done to eliminate the free exfoliated cancer cells on the peritoneal lining in order to reduce the risk of peritoneal recurrence.
A multi-institutional prospective, randomized trial has been launched by Kuramoto recently. The trail was intended to demonstrate the superiority in overall survival of addition of Extensive Intraoperative peritoneal Lavage (EIPL) to standard treatment in patients with≥T3 carcinoma of stomach. Based on the'limiting dilution theory', after total or distal gastrectomy with D2 lymphadenectomy, the peritoneal cavity is extensively rinsed 10 times with 1 L physiological saline at a time, followed by complete aspiration of the fluid. In total, 10 L saline is to be used. In this study, the EIPL-IPC group had a significantly lower incidence of peritoneal recurrence. Furthermore, the 5-year overall survival rate of the patients in the EIPL-IPC group (43.8%) was significantly better than that of the intraperitoneal chemotherapy (IPC) group (4.6%) and the surgery-alone group (0%). All in all, EIPL is easy to carry out, safe and inexpensive. Therefore, gastrectomy with EIPL will be a new standard treatment of gastric cancer.
To ensure the quality of the study, two interim analyses will be planned at the half and the completion of the study respectively. The Data and Safety Monitoring Committee will independently review the interim analysis and stop the study ahead of schedule if necessary. Furthermore, to improve the study progress and quality, the in-house interim monitoring will be performed.
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
- Single (Participant)
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
- •Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
- •ECOG score standard (ECOG）performance status of 0 or 1 and expected to survive more than 6 months.
- •Without any other malignancies.
- •Written informed consent from the patient.
- •Histologically proven primary gastric adenocarcinoma.
- •Patients planned for open gastrectomy.
- •Patients who have T3 (subserosal) or T4 (serosal) disease based on Ultrasound gastroscopy and intra-operative inspection with any N staging and M0 gastric cancer.
- •No preoperative neoadjuvant chemotherapy.
- •Length of esophageal invasion≤3cm and no need of thoracotomy for resection.
- •Intraoperative inclusion criteria:
- •Clinically T3, T4a or T4b.
- •Clinically H0 and M
- •No peritoneal dissemination or Distant metastases.
- •Possible for R0 surgery.
排除标准
- •Female in pregnancy or lactation.
- •Supraclavicular lymph nodes metastases，pelvis or ovarian implantation，peritoneal dissemination，liver，lung and bone metastases.
- •Massive ascites or cachexia.
- •Patients participating in any other clinical trails currently，or participated in other trails within 1 months.
- •Without a history of stomach or esophageal cancers, including stromal tumor，sarcoma，lymphoma and carcinoid.
- •Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- •Patients with poor compliance or considered to be poor compliance.
结局指标
主要结局
Overall survival
时间窗: 3-year
The survival rate between the surgery to the 3rd year due to all-cause death or last follow-up.
次要结局
- Post-operative quality of life(an average of 10 days)
- Disease-free survival(3-year)
- Peritoneal recurrence(3-year)
- Postoperative complications(an average of 10 days)
研究者
Dazhi Xu
Study Chair
Sun Yat-sen University