NCT01836991Unknown2 期
Phase 2 Study of D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the overall survival time
研究概览
简要总结
The purpose of this study is to evaluate the safety and the effect of D2 and D2+ radical surgery for the treatment of advanced distal gastric cancer.
详细描述
To evaluate the safety and the disease-free survival time(DFS) and overall survival time(OS) of D2 and D2+ radical surgery for the treatment of advanced distal 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
- •Male and female aged 18 to 70 years old.
- •The preoperative evaluation: distal gastric cancer patients, ≥ T2 or N +; or staging II, IIIA, IIIB.
- •Karnofsky score ≥ 70, life expectancy > 6 months.
- •Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors.
- •the blood and biochemical indicators of the subjects must meet the following criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3;
- •GOT, GPT within twice the institutional limit,serum total bilirubin < 1.5 times the upper limit of normal, serum creatinine< 1.25 times the upper limit of normal
- •have not received prior chemotherapy, radiotherapy and biological therapy. signed informed consent.
- •must accept the standard D2 or D2 + radical gastrectomy.
- •with good compliance.
排除标准
- •pregnancy, breast-feeding women.
- •allergy with chemotherapy drugs or metabolic disorder.
- •the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation).
- •had long received systemic steroid treatment (Note: short-term users of withdrawal > 2 weeks can be selected.)
- •The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
- •patients with severe infection requires treatment.
- •patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation.
- •severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes.
- •with other malignancies which were not cured.
- •EKG abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction. Coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction.
研究组 & 干预措施
D2 surgery
Other
D2 surgery(No.1、No.3、No.4sb、No.4d、No.5、No.6、No.7 and No.8a、No.9、No.11p、No.12a lymph node)
干预措施: surgery (Procedure)
D2+ surgery
Experimental
D2+ surgery(D2+8p、12b、13、14v lymph node)
干预措施: surgery (Procedure)
结局指标
主要结局
the overall survival time
时间窗: 3 years
the disease-free survival time
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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