- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164892
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
November 16, 2005 updated by: Chinese University of Hong Kong
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.
Study Overview
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.
Study Type
Interventional
Enrollment
214
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, China
- Combine Gastro-intestinal Cancer Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Recurrence free survival and the quality of life score within the two years of study period
|
Secondary Outcome Measures
Outcome Measure |
---|
Overall survival in long term
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Enders K.W. Ng, MD, Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
November 17, 2005
Last Update Submitted That Met QC Criteria
November 16, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Rofecoxib
Other Study ID Numbers
- CRE-2001.463-T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer of Stomach
-
Chinese University of Hong KongRecruiting
-
ASLAN PharmaceuticalsCompletedStomach Neoplasms | Gastric Cancer | Gastric Neoplasms | Cancer of Stomach | Cancer of the StomachKorea, Republic of
-
Enzon Pharmaceuticals, Inc.TerminatedCancer of Stomach | Gastroesophageal Cancer
-
Chinese University of Hong KongUnknown
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedStage IV Gastric Cancer | Recurrent Gastric Cancer | Stage III Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the StomachUnited States
-
Eastern Cooperative Oncology GroupNational Cancer Institute (NCI); ECOG-ACRIN Cancer Research GroupWithdrawnGastrointestinal Cancer | Adenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Adenocarcinoma of the Esophagus | Stage IV Esophageal Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric... and other conditionsUnited States
-
City of Hope Medical CenterActive, not recruitingAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditionsUnited States
Clinical Trials on Oral Vioxx (Rofecoxib)
-
Chinese University of Hong KongUnknown
-
M.D. Anderson Cancer CenterTerminated
-
Hospital Universitario Pedro ErnestoCompletedAntiphospholipid Antibody Syndrome
-
Merck Sharp & Dohme LLCCompleted
-
Cancer Research Campaign Clinical Trials CentreCompletedColorectal CancerUnited Kingdom
-
Merck Sharp & Dohme LLCCompleted
-
Tremeau Pharmceuticals, Inc.TerminatedHemophilic ArthropathyUnited States, Italy, Turkey, Spain, Australia, Canada, Ukraine, Poland
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted