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 - Full Text View

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 III

MedlinePlus related topics:

Cancer Palliative Care Stomach Cancer

Drug Information available for:

Rofecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165048

Locations


China
	Combined Gastro-intestinal Cancer Clinic
	Hong Kong, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators


Principal Investigator:	Enders K.W. Ng, MD	Chinese University of Hong Kong

More Information

Study ID Numbers:	CRE-2001.462-T
First Received:	September 12, 2005
Last Updated:	December 8, 2005
ClinicalTrials.gov Identifier:	NCT00165048
Health Authority:	Hong Kong: Department of Health

Study placed in the following topic categories:

Stomach Diseases

Digestive System Diseases

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Neoplasms

Rofecoxib

Gastrointestinal Neoplasms

Stomach cancer

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2008

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00165048