Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 11:49 AM
Study NCT ID:
NCT00623558
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2008-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2008-02-17', 'studyFirstSubmitQcDate': '2008-02-17', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'after induction treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['head and neck neoplasm', 'cetuximab', 'docetaxel', 'cisplatin', 'radiotherapy'], 'conditions': ['Head and Neck Neoplasm']}, 'referencesModule': {'references': [{'pmid': '26304911', 'type': 'DERIVED', 'citation': 'Lee KW, Koh Y, Kim SB, Shin SW, Kang JH, Wu HG, Sung MW, Keam B, Kim DW, Kim TM, Kim KH, Kwon TK, Hah JH, Kim IA, Ahn SH, Yoon DH, Lee SW, Kim SY, Nam SY, Jung KY, Baek SK, Hong SH, Lee SH, Heo DS. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015 Oct;20(10):1119-20. doi: 10.1634/theoncologist.2015-0208. Epub 2015 Aug 24.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unresectable, locally advanced (cT4b \\&/or cN2-3) HNSCC\n* ECOG performance status 0-1\n* Age 18 or older than 18 years\n* Measurable disease by RECIST criteria\n* Having signed informed consent\n* ALT and AST\\<2.5 times ULN\n* Serum albumin level ≥3.0g/dL\n* Serum AKP \\< 2.5 times ULN\n* Bilirubin level \\< 1.5mg/dL\n* Serum creatinine \\<1.5 times ULN\n* WBC\\>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet\\>75,000/mm3, Hb\\>9g/dl\n\nExclusion Criteria:\n\n* Previous cytotoxic chemotherapy for HNSCC\n* Radiotherapy for targeted lesions within six months\n* Previous EGFR pathway-targeting therapy\n* Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry)\n* Distant metastatic disease\n* Heart failure, coronary artery disease, myocardial infarction within the last 6 months\n* Known allergy to any study treatment\n* Pregnancy or lactation period\n* Any investigational agent within the past 28 days\n* Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer\n* Legal incapacity'}, 'identificationModule': {'nctId': 'NCT00623558', 'briefTitle': 'Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Randomized, Multicenter, Open Phase II Study of Cetuximab With Docetaxel, Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)', 'orgStudyIdInfo': {'id': 'CRCST-L0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Docetaxel+CDDP', 'interventionNames': ['Drug: Docetaxel', 'Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Docetaxel+CDDP+Cetuximab', 'interventionNames': ['Drug: Cetuximab', 'Drug: Docetaxel', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'description': '400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks', 'armGroupLabels': ['2']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': '75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)', 'armGroupLabels': ['1', '2']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dae Seog Heo, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Center for Solid Tumors, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Research Center for Solid Tumor, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dae Seog Heo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}