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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Chinese University of Hong Kong.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00165048
First received: September 12, 2005
Last updated: December 8, 2005
Last verified: September 2005
  Purpose

The purpose of this study is to investigate the effect of selective COX-II inhibitor in patients with regionally disseminated stomach cancer treated by palliative resection (so called R1 or R2 gastrectomy).


Condition Intervention Phase
Cancer of Stomach
Drug: Vioxx (Rofecoxib)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Symptom-free susrvival and the quality of life score within the two years of study period.

Secondary Outcome Measures:
  • Overall survival in long-term.

Estimated Enrollment: 206
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 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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165048

Locations
China
Combined 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

No publications provided

ClinicalTrials.gov Identifier: NCT00165048     History of Changes
Other Study ID Numbers: CRE-2001.462-T
Study First Received: September 12, 2005
Last Updated: December 8, 2005
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 29, 2014