NCT00164892

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

November 17, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

November 16, 2005

Conditions

Cancer of Stomach

Outcome Measures

Primary Outcomes (1)

  • Recurrence free survival and the quality of life score within the two years of study period

Secondary Outcomes (1)

  • Overall survival in long term

Interventions

Oral Vioxx (Rofecoxib)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resectable advanced stomach cancer (Tumour stage ≥ T2N1 according to the 5th edition of UICC staging system) without peritoneal or distant metastases.
  • Normal renal function

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combine Gastro-intestinal Cancer Clinic

Hong Kong, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

rofecoxib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Enders K.W. Ng, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

October 1, 2004

Last Updated

November 17, 2005

Record last verified: 2005-09

Locations

CN(1)