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”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Vioxx (Rofecoxib)

Primary Measures

• Symptom-free susrvival and the quality of life score within the two years of study period.

Secondary Measures

• Overall survival in long-term.

Inclusion Criteria:

• Stomach cancer with peritoneal or lymphatic spread beyond the scope of curative resection
• Palliative resection can be performed
• Normal RFT

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Chinese University of Hong Kong

Overall Clinical Trial Officials and Contacts

Enders K.W. Ng, MD Principal Investigator Chinese University of Hong Kong  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00165048

Study ID Number: CRE-2001.462-T

ClinicalTrials.gov Identifier: NCT00165048

Health Authority: Hong Kong: Department of Health