Phase III Study of the Effect of Radical Gastric Surgery Versus Conventional Surgery on Recurrence and Survival in Patients With Advanced Stage Gastric Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 主要终点
- We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.
研究概览
简要总结
- OBJECTIVES To determine in a prospective randomized clinical trial, the effect of extended lymph node dissection (R3 gastrectomy) versus conventional surgery (R0/1 gastrectomy) on tumor recurrence and survival in Chinese patients with advanced cancer of the stomach (adenocarcinoma invasion beyond submucosa).
- STATISTICAL CONSIDERATIONS The major end points are disease free survival and survival. The log-rank test will be used as analytic method on disease-free survival and overall durvival. The follow-up time after treatment is five years.
Previous experience provides an estimation of a 20% 5-year survival rate with conventional surgery for gastric cancer. Assuming that this new treatment (radical surgery) may increase the 5-year survival rate to 40%, we estimate that 118 evaluable patients are required to detected a significance at a of 0.05 level and power of 0.8 using a one tailed test.
We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.
详细描述
* TREATMENT PLAN
Patients are randomized intraoperatively into arm I (conventional [R0/R1] gastrectomy) or arm II (extended radical [R3] lymph node dissection).
Arm I: Resection of stomach, greater omentum, lesser omentum, and adjacent organ(s) when the primary tumor invaded directly. A total or distal subtotal gastrectomy is decided by the proximal distance from cardia to the tumor. A margin of 3 cm was required for well-defined (Borrmann I or II) tumors, and of 5 cm for ill-defined (Borrmann III or IV) tumors. When a total gastrectomy is performed, the distal pancreas and spleen should be preserved unless there is direct invasion into these organs. The left gastric artery should not be ligated at its origin but distal to its bifurcation into ascending and descending branches.
Arm II: The procedure are the same as in Arm I, additionally, extended lymph node dissection includes dissection of the N1, N2 and N3 nodes. These groups (N) are comprised of lymph node stations which depended on the location of the primary tumors (Fig. 1).
- For N2 dissection, the left gastric artery is ligated at its origin to facilitate the dissection of No.7. If a total gastrectomy is indicated, a splenectomy is essential for the dissection of station No. 10, and a distal pancreatectomy for the dissection of station No.11. Combined resection of these adjacent organs is not performed during a distal subtotal gastrectomy.
- If the primary cancer is located at the middle or lower third of stomach, No.1 (nodes at right cardiac) and 11 (nodes along the splenic artery) are excised routinely for frozen section before gastric resection. If no cancer metastasis is seen in both No.1 and 11 lymph nodes is performed. If only No. 1 lymph nodes is positive for cancer metastasis, total gastrectomy is performed instead of distal subtotal resection. If No. 11 lymph nodes are positive, splenectomy and distal pancreatectomy are performed in addition to the radical resection of the stomach and lymph nodes.
- For N3 dissection: No. 12 (nodes in the hepatoduodenal ligament), No. 13 (nodes at retropancreatic region) and No. 14 (nodes at the root of mesentery) are dissected.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Patients with histologically proven adenocarcinoma of the stomach.
- •No clinical early stage stomach cancer (mucosa or submucosal invasion only).
- •No esophageal invasion.
- •No distant metastatic disease.
- •No para-aortic, macrolymphadenopathy
- •No N3, macrolymphadenopathy
- •Suitable for gastric surgery with curative intent.
- •Medically fit for surgery.
- •No emergency resection required.
- •No previous gastrectomy.
- •Not older than 75 years.
- •Signed informed consent form.
- •No previous or concomitant other cancer.
排除标准
- •Patients is not adenocarcinoma of the stomach.
- •distant metastatic disease.
- •previous gastrectomy.
- •older than 75 years.
结局指标
主要结局
We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.
次要结局
未报告次要终点