A Randomized, Single Center, Controlled Phase II Study to Compare Laparoscopic Versus Open Distal Gastrectomy in Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- 3-year progression-free survival
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of laparoscopic distal D2 gastrectomy (LDG) compared with open surgery (ODG) for resectable gastric cancer, to determine whether LDG can be a test arm for a future Phase III trial to evaluate the non-inferiority of overall survival compared with ODG in patients who receive neoadjuvant chemotherapy.
详细描述
The study is an open-label, controlled, randomized Phase II clinical trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital.
The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival, surgical morbidity and mortality.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma of the stomach.
- •Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy. The T and N stages are determined by the method of Habermann et al.
- •The gastric tumors are located in the middle to lower third of the stomach, are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
- •No bulky lymph node metastasis is detected by abdominal CT.
- •No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
- •No clinically apparent distant metastasis.
- •Karnofsky performance status ≥70%.
- •Sufficient oral intake.
- •No previous treatment with chemotherapy or radiation therapy for any tumors.
- •No previous surgery for the present disease.
- •Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses.
- •White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0*104/mm3 (5.0*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
- •No need for emergency surgery due to bleeding or perforation of the primary tumor.
- •No mechanical obstruction.
- •Written informed consent.
排除标准
- •Past history of upper abdominal surgery.
- •Past history of surgery for the gastrointestinal tract.
- •Body mass index exceeding 30 kg/m2.
研究组 & 干预措施
Laparoscopic gastrectomy
Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
干预措施: Neoadjuvant Chemotherapy (Drug)
Laparoscopic gastrectomy
Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
干预措施: Laparoscopic gastrectomy (Procedure)
Laparoscopic gastrectomy
Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
干预措施: Adjuvant Chemotherapy (Drug)
Open gastrectomy
Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
干预措施: Neoadjuvant Chemotherapy (Drug)
Open gastrectomy
Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
干预措施: Open gastrectomy (Procedure)
Open gastrectomy
Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
干预措施: Adjuvant Chemotherapy (Drug)
结局指标
主要结局
3-year progression-free survival
时间窗: 36 months
In terms of locally advanced gastric cancer, to evaluate the disease free survival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection
次要结局
- Postoperative recovery index(2 weeks)
- Overall survival(36 months)
- Surgical morbidity(30 days)
- Postoperative quality of life(Up to 1 year post-operative)
- Surgical mortality(30 days)
研究者
Ziyu Li, MD
Chief Physician,Associate Professor
Peking University