A Multicenter Randomized Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 1,880
- 试验地点
- 50
- 主要终点
- overall survival
研究概览
简要总结
In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric cancer in advanced gastric cancer (stage IB/IIA/IIB ).
详细描述
■ Background of Hypothesis A. JCOG (Japanese Clinical Oncology Group) 9501 Study
: Addition of aorta lymph node dissection to D2 lymph node dissection does not increase survival rate.
Wide range of operation is not always the best treatment. If invasion rate can be kept as minimal as possible while maintaining survival rate, it can lead to more secure operation while also reducing the frequency of complication after the surgery. 20 It may be advantageous for patients in terms of operation time, cost, and quality of life.
B. COACT 1001 study A previous study which compared the feasibility of lymph node dissection in open surgery and lapraroscopic surgery for advanced gastric cancer.
11p, 12a lymph node (D2) resection rate: 79.2% and 88.8% respectively in all advance 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven primary gastric adenocarcinoma
- •T1N1, T2N0, T2N1, T3N0, T3N1 by CT scan (AJCC 7th classification) and intraoperative surgical staging prior to resectional procedure
- •Location of primary tumor; antrum, or angle, lower body or mid body of the stomach
- •No evidence of other distant metastasis
- •Aged ≥ 20 year old
- •Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- •No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
- •Adequate organ functions defined as indicated below:
- •WBC 3000/mm3 - 12,000/mm3
- •>serum Hemoglobin 8.0 g/dl
- •> serum Platelet 100 000/mm3
- •< serum AST 100 IU/l
- •<serum ALT 100 IU/l
- •< Total Bilirubin 2.0 mg/dl
- •Written signed informed consent
排除标准
- •Active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
- •Gastric remnant cancer
- •≥T4a in surgical staging before resection
- •N2 or more (number of metastatic lymph nodes ≥3) in CT scan
- •Histologically rare variants in WHO Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, , neuroendocrine carcinoma and others
- •Pregnant or breast-feeding women
- •Mental disorder(diagnosed with mental disorder on medical record)
- •systemic administration of corticosteroids(include Herbal Medication)
- •unstable angina or myocardial infarction within 6 months of the trial
- •unstable hypertension
- •severe respiratory disease requiring continuous oxygen therapy
- •previous upper abdominal surgery except laparoscopic cholecystectomy
研究组 & 干预措施
D2 distal subtotal gastrectomy
D2 distal subtotal gastrectomy D2 includes Nos.1.3,4sb,4d,5,6,7,8a,9,11p,and 12a nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy
干预措施: D2 distal subtotal gastrectomy (Procedure)
D1+ distal subtotal gastrectomy
D1+ distal subtotal gastrectomy D1+ includes Nos.1,3,4sb,4d,5,6,7,8a,and 9 nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy
干预措施: D1+ distal subtotal gastrectomy (Procedure)
结局指标
主要结局
overall survival
时间窗: 5 year
To test non-inferiority of survival of D1+ gastrectomy versus D2 gastrectomy for clinical stage I B \& II advanced gastric cancer
次要结局
- Finding biomarkers predicting lymph node metastasis and recurrence(3 year)
- Long term postoperative complications(after 30 days)
- Operating time(op day)
- disease free survival(3 year)
- Overall cost for the treatment(operation day to discharge)
- Subgroup analysis of Laparoscopic surgery versus open surgery(3 year , 5 year)
- Early postoperative complications(within 30 days)
- Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)(baseline, 1 week, 1month, 6 month, 1 year, 3 year)
研究者
Young-Woo Kim
Head of Gastric Cancer Branch
National Cancer Center, Korea