Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
Study NCT ID:
NCT00164892
Status:
UNKNOWN
Last Update Posted:
2005-11-17
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C116926', 'term': 'rofecoxib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 214}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2005-11-16', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2005-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence free survival and the quality of life score within the two years of study period'}], 'secondaryOutcomes': [{'measure': 'Overall survival in long term'}]}, 'conditionsModule': {'conditions': ['Cancer of Stomach']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resectable advanced stomach cancer (Tumour stage ≥ T2N1 according to the 5th edition of UICC staging system) without peritoneal or distant metastases.\n* Normal renal function\n\nExclusion Criteria:\n\n* Solid organ metastases\n* Poor performance status\n* Already on long-term aspirin or NSAID\n* Renal or hepatic dysfunction\n* Bleeding disorder\n* Hypersensitive to COX-II inhibitors/aspirin/NSAID\n* No history of myocardial infarct or stoke'}, 'identificationModule': {'nctId': 'NCT00164892', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CRE-2001.463-T'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oral Vioxx (Rofecoxib)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Combine Gastro-intestinal Cancer Clinic', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Enders K.W. Ng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}}}}