This trial is active, not recruiting.

Condition cancer of stomach
Treatment oral vioxx (rofecoxib)
Phase phase 3
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Recurrence free survival and the quality of life score within the two years of study period
time frame:

Secondary Outcomes

Overall survival in long term
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2005.
Information provided to ClinicalTrials.gov by Chinese University of Hong Kong.