Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial
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About
The purpose of this study is to investigate the efficacy of selective COX-II inhibitor in patients with curative resection performed for locally advanced stomach cancer.
Full description
Cyclo-oxygenase (COX) is a family of enzymes regulating the conversion of arachidonic acid to prostaglandins. COX-II is an inducible enzyme, which may be upregulated when there are stimuli such as inflammation or hypergastrinaemia. Despite radical surgery, patients with stomach cancer of advanced stages often have a poor prognosis. Reported survival in those with diseases of stage IIIa or above is less than 40%. Methods to improve patients outcome have been explored for decades with little success. In the light of current understanding on the relation between COX-II and stomach cancer, selective COX-II inhibitor may be used as a novel adjuvant therapy after gastrectomy to prevent recurrence of gastric carcinoma. The advantages of COX-II inhibitors are being relatively non-toxic with minimal side effect.
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Volunteers
Inclusion criteria
- Resectable advanced stomach cancer (Tumour stage ≥ T2N1 according to the 5th edition of UICC staging system) without peritoneal or distant metastases.
- Normal renal function
Exclusion criteria
- Solid organ metastases
- Poor performance status
- Already 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 stoke
Trial design
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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