Selective COX-II Inhibitor as a Palliative Therapy in Patients With R1 or R2 Resection for Disseminated Stomach Cancer - A Multi-Centre Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Symptom-free susrvival and the quality of life score within the two years of study period.
研究概览
简要总结
The purpose of this study is to investigate the effect of selective COX-II inhibitor in patients with regionally disseminated stomach cancer treated by palliative resection (so called R1 or R2 gastrectomy).
详细描述
Cyclo-oxygenase (COX) is a family of enzymes regulating the conversion of arachidonic acid to prostaglandins. COX-II is an inducible enzyme, which expresses excessively when there are stimuli such as inflammation or hypergastrinaemia. Up to 40% of patients with stomach cancer are found to have disseminated disease during surgical exploration. While palliative resection could offer a marginal benefit in the survival of these patients, almost all patients will die of progression of disease within a short time span. Palliative chemotherapy has been used in the past. However, there is no evidence that the chemotherapy can confer any survival advantages, and the side-effects and toxicity of the treatment may indeed compromise the quality of life of these patients. With a better understanding of the relation between COX-II and stomach cancer, it may be possible to suppress the progression of the residual cancer cells after the palliative resection by giving the patients selective COX-II inhibitors.
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
- Double
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
- •Stomach cancer with peritoneal or lymphatic spread beyond the scope of curative resection
- •Palliative resection can be performed
- •Normal RFT
排除标准
- •Solid organ metastases
- •Poor performance status
- •On long-term aspirin or NSAID
- •Renal or hepatic dysfunction
- •Bleeding disorder
- •Hypersensitive to COX-II inhibitors/aspirin/NSAID
- •No history of myocardial infarct or stroke
结局指标
主要结局
Symptom-free susrvival and the quality of life score within the two years of study period.
次要结局
- Overall survival in long-term.
