Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-29 @ 9:48 AM
Study NCT ID:
NCT01080066
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2010-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
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': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2010-02-18', 'studyFirstSubmitQcDate': '2010-03-02', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse drug reactions and serious adverse drug reactions', 'timeFrame': 'From the first infusion of cetuximab until three months after the last infusion of Cetuximab'}, {'measure': 'Number of subjects discontinuing the study due to intolerability of cetuximab', 'timeFrame': 'From the first infusion of cetuximab until three months after the last infusion of Cetuximab'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with best tumor response categories that are, complete response, partial response, stable disease, progressive disease and not evaluable', 'timeFrame': 'From the first infusion of cetuximab until three months after the last infusion of cetuximab'}, {'measure': 'Time to progression', 'timeFrame': 'From the first infusion of cetuximab until three months after the last infusion of cetuximab'}, {'measure': 'Duration of response', 'timeFrame': 'From the first infusion of cetuximab until three months after the last infusion of cetuximab'}, {'measure': 'Overall Survival', 'timeFrame': 'From the first infusion of cetuximab to death until three months after the last infusion of cetuximab'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carcinoma', 'Squamous cell', 'Erbitux', 'cetuximab', 'Head', 'Neck'], 'conditions': ['Carcinoma, Squamous Cell of Head and Neck']}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational, non-interventional, multicenter, post-marketing surveillance study to mainly collect safety information from subjects with locally advanced and recurrent/metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) treated with cetuximab based on the locally approved label.', 'detailedDescription': "Cetuximab is an immunoglobulin G1 (IgG1) monoclonal antibody that enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. This prospective, observational, non-interventional and multi-centric post marketing surveillance study is being conducted to collect safety information from subjects with locally advanced or recurrent/metastatic SCCHN treated with cetuximab based on the locally approved label. Study plans to enroll 200 to 300 subjects, who are eligible for cetuximab treatment according to the indication in the approved label of cetuximab by Taiwan Health Authority. Data related to subjects' demographics, relevant tumor history, and laboratory information (hematology, biochemistry) will be captured and analyzed descriptively.\n\nOBJECTIVES\n\nPrimary objective:\n\n• To obtain safety information on the use of cetuximab in subjects with SCCHN according to the regulatory approved label and in a regular clinical setting\n\nSecondary objectives:\n\n• To gather clinical efficacy information of the treatment"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with SCCHN and are eligible to receive cetuximab and radiotherapy according to the local label', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven Stage 3-4 locally advanced SCCHN (oropharynx, hypopharynx, larynx) or recurrent and/or metastatic SCCHN\n* Age greater than or equal to 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Subjects with known severe (Grade 3 or 4; National Cancer Institute Common Toxicity Criteria Version 4.03) hypersensitivity reactions to Cetuximab\n* Subjects with contraindications for concomitantly used chemotherapeutic agents or radiation therapy, identified before initiation of cetuximab combination treatment'}, 'identificationModule': {'nctId': 'NCT01080066', 'briefTitle': 'A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)', 'orgStudyIdInfo': {'id': 'EMR62202-512'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-Interventional Study', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'otherNames': ['Erbitux®'], 'description': 'Subjects administered with Cetuximab, once weekly by intravenous infusion at a first dose of 400 milligram per square meter (mg/m\\^2) body surface area for 120 minutes infusion period and subsequently at a dose of 250 mg/m\\^2 for 60 minutes infusion period, will be observed. The maximum infusion rate must not exceed 10 milligram per minute (mg/min).', 'armGroupLabels': ['Non-Interventional Study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Liuying', 'state': 'Tainan County', 'country': 'Taiwan', 'facility': 'Liouying Chi-Mei Hospital', 'geoPoint': {'lat': 23.27833, 'lon': 120.31444}}], 'overallOfficials': [{'name': 'Chao-Jung Tsao, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liouying Chi-Mei Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Choice Pharma Taiwan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}