Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Long-term Outcomes Between Laparoscopic And Open Total Gastrectomy In Patients With Locally Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,018
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0). The primary purpose of this study is to evaluate the overall survival and determine the efficacy of LTG compared with OTG for locally advanced gastric cancer. The second purpose is to evaluate the 3-year overall survival rate, 3-year disease free survival rate, morbidity and mortality rates, 3-year recurrence pattern and postoperative recovery course of the patients enrolled in this study.
详细描述
Gastric cancer is a significant global health problem, especially in East Asia. With an increase in the incidences of proximal gastric cancer over the last decades, the value of total gastrectomy is more emphasized. Laparoscopic total gastrectomy (LTG) has become an attracting option for surgeons due to its well-known advantages. However, more evidence is needed to support the safety and efficacy of LTG in locally advanced gastric cancer.
Recently，a multicenter, open-label, noninferiority, randomized clinical trial (CLASS-02) launched by Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group compared the safety of LTG for clinical stage I gastric cancer with open total gastrectomy (OTG). The overall morbidity and mortality rates were 19.1% in the LTG group and 20.2% in the OTG group, which was not significantly different (rate difference, -1.1%). This study demonstrated that LTG can be safely performed by experienced surgeons for clinical stage I gastric cancer. However, there hasn't been any prospective randomized clinical trial study evaluating the safety and efficacy of LTG in advanced gastric cancer.
This CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between LTG and OTG in patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0). The primary purpose of this study is to evaluate the overall survival and determine the efficacy of LTG compared with OTG for locally advanced gastric cancer. The second purpose is to evaluate the 3-year overall survival rate, 3-year disease free survival rate, morbidity and mortality rates, 3-year recurrence pattern and postoperative recovery course of the patients enrolled in this study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years
- •Tumor located in the middle or upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
- •Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
- •Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system);
- •Expected survival > 6 months
- •No invasion to Z-line;
- •BMI (Body Mass Index) < 30 kg/m2
- •No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
- •No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc
- •Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
- •Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
- •Sufficient organ functions
- •Written informed consent
排除标准
- •Preoperative examinations indicate regional fusion of enlarged lymph nodes (max diameter ≥ 3.0cm) or enlargment of spleen hilus lymph nodes
- •Women during pregnancy or breast-feeding
- •Synchronous or metachronous (within 5 years) malignancies
- •Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated
- •Severe mental disease
- •Severe respiratory disease, FEV1 < 50% of predicted
- •Severe hepatic and renal dysfunction
- •Unstable angina pectoris or history of myocardial infarction within 6 months
- •History of cerebral infarction or cerebral hemorrhage within 6 months
- •Continuous systemic steroid therapy within 1 month (except for topical use)
- •Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery
- •Patients are participating or have participated in another clinical trial (within 6 months)
研究组 & 干预措施
Laparoscopic total gastrectomy
The surgeon will perform LTG with D2 lymphadenectomy for patients enrolled in this group.
干预措施: Laparoscopic total gastrectomy (Procedure)
Open total gastrectomy
The surgeon will perform OTG with D2 lymphadenectomy for patients enrolled in this group.
干预措施: Open total gastrectomy (Procedure)
结局指标
主要结局
Overall survival
时间窗: 3 years
Overall survival (OS) was defined as the time from randomization to death from any cause
次要结局
- 3-year overall survival rate(3 years)
- 3-year disease free survival rate(3 years)
- Early morbidity rate(30 days)
- Early mortality rate(30 days)
- 3-year recurrence pattern(3 years)
- Postoperative recovery course(30 days)
- 3-year disease free survival rate(3 years)
- 3-year overall survival rate(3 years)
- Early morbidity rate(30 days)
- Early mortality rate(30 days)
- 3-year recurrence pattern(3 years)
- Postoperative recovery course(30 days)