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

Cancer of Stomach Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00164892
• Other study ID #: CRE-2001.463-T
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 16, 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 efficacy of selective COX-II inhibitor in patients with curative resection performed for locally advanced stomach cancer.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer of Stomach
• Stomach Neoplasms

Intervention

Drug:
• Oral Vioxx (Rofecoxib)

Locations

Country	Name	City	State
China	Combine 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	Recurrence free survival and the quality of life score within the two years of study period
Secondary	Overall survival in long term