Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-16 @ 1:34 AM
Study NCT ID:
NCT02739204
Status:
UNKNOWN
Last Update Posted:
2016-04-15
First Post:
2016-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concurrent Radiotherapy and/or Cisplatin With or Without Celecoxib in Patients With Primary Oral Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2016-03-22', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free recurrence', 'timeFrame': '3 year relapse-free recurrence', 'description': '3-year follow-up after 6-month treatment of Celecoxib'}], 'secondaryOutcomes': [{'measure': 'Relapse-free survival', 'timeFrame': '3 year relapse-free survival', 'description': '3-year follow-up after 6-month treatment of Celecoxib'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Celecoxib', 'Relapse-free OSCC patient', 'Recurrence', 'Survival', 'Prognosis'], 'conditions': ['Oral Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The research and development of novel anti-tumor agents in oral cancer is slow, the investigation of repositioning use of currently available drugs in clinical, such as a selective cyclooxygenase-2 (COX-2) inhibitor (Celebrex/Celecoxib) maybe a potential alternative strategy.', 'detailedDescription': 'Celebrex (Celecoxib) is a form of non-steroidal anti-inflammatory drug that directly targets COX-2 enzyme to block the inflammatory signaling and has been approved to treat colon cancer. In our preliminary findings, Celecoxib significantly inhibited cell growth,proliferation, migration, invasion and epithelial-mesenchymal transition programs in oral squamous cell carcinoma cell (OSCC) lines. The Institutional Review Board in China Medical University Hospital (CMUH) has approved the combination treatment of concurrent radiotherapy (RT) and/or Cisplatin with or without Celecoxib in a phase II clinical trial for relapse-free primary OSCC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. OSCC patients with T1,2/ N0 and without pathological risk features\n2. OSCC patients with T1,2/ N0,1 and pathological risk features\n3. OSCC patients with T4a/ N2,3\n\nExclusion Criteria:\n\n1. Pregnant women paitents\n2. Taiwanese aboriginal patients\n3. Not primary OSCC patients\n4. OSCC patients with dysfunction of liver and/or kidneys'}, 'identificationModule': {'nctId': 'NCT02739204', 'briefTitle': 'Concurrent Radiotherapy and/or Cisplatin With or Without Celecoxib in Patients With Primary Oral Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer', 'orgStudyIdInfo': {'id': 'CMUH102-REC1-071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celecoxib', 'description': 'Combination of concurrent radiotherapy and/or Cisplatin with or without Celcoxib', 'interventionNames': ['Drug: Celecoxib']}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': '200 mg of Celecoxib daily for 6-month treatment after surgery within 1 - 6 months', 'armGroupLabels': ['Celecoxib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40447', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ming-Hsul Tsai, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'minghsui@mail.cmuh.org.tw', 'phone': '886-4-22052121', 'phoneExt': '4436'}, {'name': 'Chun-Hung Hua, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Otolaryngology', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Ying-Chin Ko, MD-PhD', 'role': 'CONTACT', 'email': 'ycko0406@gmail.com', 'phone': '886-4-22052121', 'phoneExt': '7322'}], 'overallOfficials': [{'name': 'Ying-Chin Ko, MD-PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Graduate Institute of Clinical Medical Science, China Medical University, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health and Welfare, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}