A Single-center, Randomized, Controlled Trial to Evaluate Total Versus Partial Omentectomy for Advanced Gastric Cancer in Radical Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- 3 years relapse-free survival
研究概览
简要总结
The main purpose of this study is to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.
详细描述
Surgical resection is the mainstay of treatment for gastric cancer. The extent of surgical resection includes total or subtotal gastrectomy, D2 lymphadenectomy, and prophylactic or therapeutic resection of the surrounding organs or tissues (e.g., omentum, peritoneum, etc). However, the oncologic importance of omentectomy during gastrectomy remains unclear. The European guidelines do not give any advice regarding omentectomy, whereas the most recent American guidelines advise to resect both the greater and lesser omentum. Alternatively, the Japanese gastric cancer treatment guidelines recommends preservation of the greater omentum at >3 cm from the gastroepiploic arcade for patients with T1-T2 tumors and total omentectomy for patients with T3-T4 tumors. In order to evaluate the impact of omentectomy for advanced gastric cancer on patient survival, we designed this trial. Patients who received curative gastrectomy were divided into two groups based on whether they underwent omentectomy. The primary endpoint is the 3-year relapse-free survival rate and the secondary endpoints are 5-year overall survival, and postoperative morbidity.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16);
- •Physical condition and organ function allows to tolerable abdominal surgery;
- •Willing and able to comply with the program during the study period;
- •Written informed consent provided;
- •≥ 18 and ≤ 70 years of age; preoperative gastric cancer patients with pathologically confirmed;
- •With more than a 6-month life expectancy;
- •No other serious concomitant diseases; Sufficient organ functions;
- •No previous history of chemotherapy or radiotherapy;
- •All patients accept 8 cycles XELOX chemotherapy regimen;
- •Clinical stage: T2-4aN0-+M0;
- •Macroscopic types :Borrmann I-III;
- •Not greater curvature tumor;
- •No previous surgery for any abdominal disease, except an appendectomy for appendicitis, a laparoscopic cholecystectomy for gallbladder stones; No previous history of peritonitis, pancreatitis;
- •Karnofsky performance status (KPS)>60; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1.
排除标准
- •Pregnancy or breast feeding;
- •Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency;
- •Organ transplantation patients need immunosuppressive therapy;
- •Severe recurrent infections were not controlled or with other serious concomitant diseases;
- •Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years;
- •Psychiatric disease which require treatment;
- •Have the history of organ transplantation;
- •Within 6 months before study starts and in the process of this study, patients participate in other clinical researches.
- •Advanced gastric cancer with omentum invasion
- •Patients can't treated with XELOX after surgery;
- •Macroscopic types : Borrmann IV;
- •Tumor invasion of adjacent organ (T4b) or with distant metastasis（M1）;
- •Tumor invasion the greater curvature invasion.
研究组 & 干预措施
Experimental group
D2 radical gastrectomy with partial omentectomy
干预措施: Type of omentectomy (Procedure)
Control group
D2 radical gastrectomy with total omentectom
结局指标
主要结局
3 years relapse-free survival
时间窗: 3 years
Relapse-free survival l (RFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
次要结局
- 5 years overall survival(5 years)