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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
18 Years
80 Years
Open (Enrolling)
Both
Cancer of Stomach

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Enders K.W. Ng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese University of Hong Kong

Authority:

Hong Kong: Department of Health

Study ID:

CRE-2001.463-T

NCT ID:

NCT00164892

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Cancer of Stomach
  • Stomach Neoplasms

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