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
Recruitment status was Active, not recruiting
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer of Stomach |
Drug: Vioxx (Rofecoxib) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
- Symptom-free susrvival and the quality of life score within the two years of study period.
- Overall survival in long-term.
| Estimated Enrollment: | 206 |
| Study Start Date: | October 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00165048 History of Changes |
| Other Study ID Numbers: | CRE-2001.462-T |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 8, 2005 |
| Health Authority: | Hong Kong: Department of Health |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Rofecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 21, 2013