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
This trial is active, not recruiting.
|Condition||cancer of stomach|
|Treatment||oral vioxx (rofecoxib)|
|Sponsor||Chinese University of Hong Kong|
|Start date||October 2004|
|Trial size||214 participants|
|Trial identifier||NCT00164892, CRE-2001.463-T|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Recurrence free survival 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.
- Resectable advanced stomach cancer (Tumour stage ≥ T2N1 according to the 5th edition of UICC staging system) without peritoneal or distant metastases.
- Normal renal function
- 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
|Official title||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|
|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 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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