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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


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Cancer of Stomach

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Symptom-free susrvival 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-2001.462-T

NCT ID:

NCT00165048

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Cancer of Stomach
  • Stomach Neoplasms

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