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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Chinese University of Hong Kong.
Recruitment status was:  Active, not recruiting
Information provided by:
Chinese University of Hong Kong Identifier:
First received: September 12, 2005
Last updated: December 8, 2005
Last verified: September 2005
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
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

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Symptom-free susrvival and the quality of life score within the two years of study period.

Secondary Outcome Measures:
  • Overall survival in long-term.

Estimated Enrollment: 206
Study Start Date: October 2004
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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00165048

Combined Gastro-intestinal Cancer Clinic
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Enders K.W. Ng, MD Chinese University of Hong Kong
  More Information Identifier: NCT00165048     History of Changes
Other Study ID Numbers: CRE-2001.462-T
Study First Received: September 12, 2005
Last Updated: December 8, 2005

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 25, 2017