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
This trial is active, not recruiting.
|Condition||cancer of stomach|
|Sponsor||Chinese University of Hong Kong|
|Start date||October 2004|
|Trial size||206 participants|
|Trial identifier||NCT00165048, CRE-2001.462-T|
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).
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Symptom-free susrvival and the quality of life score within the two years of study period.
Overall survival in long-term.
Male or female participants from 18 years up to 80 years old.
- Stomach cancer with peritoneal or lymphatic spread beyond the scope of curative resection
- Palliative resection can be performed
- Normal RFT
- 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
|Official title||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|
|Principal investigator||Enders K.W. Ng, MD|
|Description||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.|
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