Overview

This trial is active, not recruiting.

Condition cancer of stomach
Treatment vioxx (rofecoxib)
Phase phase 3
Sponsor Chinese University of Hong Kong
Start date October 2004
Trial size 206 participants
Trial identifier NCT00165048, CRE-2001.462-T

Summary

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).

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

Measure
Symptom-free susrvival and the quality of life score within the two years of study period.
time frame:

Secondary Outcomes

Measure
Overall survival in long-term.
time frame:

Eligibility Criteria

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

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

Additional Information

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