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
Primary Purpose
Cancer of Stomach
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Oral Vioxx (Rofecoxib)
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Stomach
Eligibility Criteria
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
Sites / Locations
- Combine Gastro-intestinal Cancer Clinic
Outcomes
Primary Outcome Measures
Recurrence free survival 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
NCT00164892
First Posted
September 12, 2005
Last Updated
November 16, 2005
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00164892
Brief Title
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
Official Title
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
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 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.
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
214 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oral Vioxx (Rofecoxib)
Primary Outcome Measure Information:
Title
Recurrence free survival 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
No
Eligibility Criteria
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
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
Combine Gastro-intestinal Cancer Clinic
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs