Cancer of Stomach
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGOral Vioxx (Rofecoxib)
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival and the quality of life score within the two years of study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival in long term | — |
Countries
China
Outcome results
None listed