Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 772
- 试验地点
- 2
- 主要终点
- 3 year relapse-free survival
研究概览
简要总结
Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses.
Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery.
Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are over 20 and below 80 years old
- •Patients who have performance status of ECOG 0 or 1
- •Patients with American Society of Anesthesiology score of class I to III
- •Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
- •Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study
- •Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (cT2 ~ cT4a)
- •Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cN0 ~ cN2)
- •Patients who agree with participating in the clinical study with informed consents
- •Patients who can be followed for at least 3 years after study enrollment
排除标准
- •Patients who have possibility of distant metastasis in preoperative studies
- •Patients who have history of gastric resection with any cause
- •Patients who have complications (bleeding or obstruction) of gastric cancer
- •Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
- •Patients who are diagnosed and treated with other malignancies within 5 years
- •Vulnerable patients
- •Patients who participating or participated in other clinical trial within 6 months
研究组 & 干预措施
Laparoscopic group
Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection
干预措施: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach (Procedure)
Open group
Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection
干预措施: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach (Procedure)
结局指标
主要结局
3 year relapse-free survival
时间窗: 3 years after surgery
Non-inferiority of 3 year relapse-free survival rate after laparoscopic radical total gastrectomy and lymphadenectomy for locally advanced gastric cancer comparing with open conventional surgery. The "event" of relapse-free survival is defined as "recurrence" after 4 weeks of operation. The "censoring" is defined as non-traceable patient who cannot be confirmed with recurrence or patient who are alive without recurrence until follow-up. The "relapse-free survival time" is defined as the time from surgery to "event" or "censoring".
次要结局
- 3 year overall survival rate(3 years after surgery)
- 5 year relapse-free and overall survival(5 years after surgery)
- Morbidity (early period)(from Operation day until POD 21)
- Morbidity (late period)(from POD (Post-Operative Day) 22 until 5 years after surgery)
- Mortality(at POD 90)
- Quality of life(EORTC QLQ-C30)(12 months after surgery)
- Quality of life(EORTC QLC STO22)(12 months after surgery)