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
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 |
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).
Status | Active, not recruiting |
Enrollment | 206 |
Est. completion date | |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Combined Gastro-intestinal Cancer Clinic | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
China,
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. |
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