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

Phase 3

• Conditions: Cancer of Stomach

• Registration Number: NCT00165048
• Lead Sponsor: Chinese University of Hong Kong

Brief 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).

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 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.

Study Timeline

• Study Start: 2004-10
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-14
• Last Update Submitted: 2005-12-08
• Last Update Posted: 2005-12-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival in long-term.

Trial Locations

Locations (1)

Combined Gastro-intestinal Cancer Clinic; 🇨🇳 Hong Kong, China