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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

Primary Purpose

Cancer of Stomach

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Vioxx (Rofecoxib)

About this trial

This is an interventional treatment trial for Cancer of Stomach

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Combined Gastro-intestinal Cancer Clinic

Outcomes

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.

Full Information

NCT ID

NCT00165048

First Posted

September 12, 2005

Last Updated

December 8, 2005

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT00165048

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

October 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of Stomach

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

206 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Vioxx (Rofecoxib)

Primary Outcome Measure Information:

Title

Symptom-free susrvival and the quality of life score within the two years of study period.

Secondary Outcome Measure Information:

Title

Overall survival in long-term.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enders K.W. Ng, MD

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Combined Gastro-intestinal Cancer Clinic

City

Hong Kong

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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