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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Cancer of Stomach

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Vioxx (Rofecoxib)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Enders K.W. Ng, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Combined Gastro-intestinal Cancer Clinic

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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CRE-2001.462-T

Identifier Type: -

Identifier Source: org_study_id