Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial - Full Text View

Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial

This study is ongoing, but not recruiting participants.

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00164892

Purpose

The purpose of this study is to investigate the efficacy of selective COX-II inhibitor in patients with curative resection performed for locally advanced stomach cancer.

Condition	Intervention	Phase
Cancer of Stomach	Drug: Oral Vioxx (Rofecoxib)	Phase III

MedlinePlus related topics:

Cancer 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 an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial

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

Primary Outcome Measures:

Recurrence free survival and the quality of life score within the two years of study period

Secondary Outcome Measures:

Overall survival in long term

Estimated Enrollment:	214
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 may be upregulated when there are stimuli such as inflammation or hypergastrinaemia. Despite radical surgery, patients with stomach cancer of advanced stages often have a poor prognosis. Reported survival in those with diseases of stage IIIa or above is less than 40%. Methods to improve patients outcome have been explored for decades with little success. In the light of current understanding on the relation between COX-II and stomach cancer, selective COX-II inhibitor may be used as a novel adjuvant therapy after gastrectomy to prevent recurrence of gastric carcinoma. The advantages of COX-II inhibitors are being relatively non-toxic with minimal side effect.

Eligibility

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

Criteria

Inclusion Criteria:

Resectable advanced stomach cancer (Tumour stage ≥ T2N1 according to the 5th edition of UICC staging system) without peritoneal or distant metastases.
Normal renal function

Exclusion Criteria:

Solid organ metastases
Poor performance status
Already 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 stoke

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164892

Locations


China
	Combine 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-2001.463-T
First Received:	September 12, 2005
Last Updated:	November 16, 2005
ClinicalTrials.gov Identifier:	NCT00164892
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