NCT04843215招募中不适用
A Phase III, Multicenter, Prospective, Randomized, Controlled Clinical Trial Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer (TOP-GC)
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 950 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 950
- 试验地点
- 1
- 主要终点
- Disease Free Survival(DFS)
研究概览
简要总结
This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.
详细描述
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 purpose of this study is to prove the non-inferiority of omentum preservation compared with omentectomy in patients with T3-T4a gastric cancer.
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: T3-4aN0-+M0; 11 . Macroscopic types :Borrmann I-III;
- •Not greater curvature tumor; with distal or total gastrectomy；
- •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; 11 . 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
Experimental
Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.
干预措施: Type of omentectomy (Procedure)
Control group/D2 radical gastrectomy with total omentectom
No Intervention
Control group with total omentectomy
结局指标
主要结局
Disease Free Survival(DFS)
时间窗: 3 years
Disease Free Survivalof the Participants
次要结局
- Overall Survival(OS)(5 years)
研究者
研究点 (1)
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