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

Phase 3

• Conditions: Cancer of Stomach

• Registration Number: NCT00164892
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

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.

Study Timeline

• Study Start: 2004-10
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Last Update Submitted: 2005-11-16
• Last Update Posted: 2005-11-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival in long term

Trial Locations

Locations (1)

Combine Gastro-intestinal Cancer Clinic; 🇨🇳 Hong Kong, China