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临床试验/NCT00165048
NCT00165048Unknown3 期

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2004年10月最近更新:
适应症
相关药物

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

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.

研究者

申办方类型
Other

研究点 (1)

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