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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00165048
Other study ID # CRE-2001.462-T
Secondary ID
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
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

Study Design

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


Related Conditions & MeSH terms


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.
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