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

Cancer of Stomach Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00165048
• Other study ID #: CRE-2001.462-T
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 8, 2005
• Start date: October 2004

Study information

• Verified date: September 2005
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 206
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of Stomach
• Stomach Neoplasms

Intervention

Drug:
• Vioxx (Rofecoxib)

Locations

Country	Name	City	State
China	Combined Gastro-intestinal Cancer Clinic	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom-free susrvival and the quality of life score within the two years of study period.
Secondary	Overall survival in long-term.