Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT01827956
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2012-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-15', 'releaseDate': '2025-08-27'}, {'resetDate': '2025-10-09', 'releaseDate': '2025-09-16'}, {'releaseDate': '2025-12-09'}], 'estimatedResultsFirstSubmitDate': '2025-08-27'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-09', 'studyFirstSubmitDate': '2012-11-05', 'studyFirstSubmitQcDate': '2013-04-09', 'lastUpdatePostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main objective is to evaluate the role of FCGR3A and FCGR2A receptor polymorphism in cetuximab and chemotherapy response, in patients with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract', 'timeFrame': 'Proportion of patients with positive response to treatment at 4 months', 'description': 'The main objective is to evaluate the role of FCGR3A and FCGR2A receptor polymorphism in cetuximab and chemotherapy response, in patients with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival Overall survival Toxicity', 'timeFrame': 'Progression-free survival: Tumour evaluation will be done at baseline and at 4 months or until the earlier of the following events: disease progression, patient death.', 'description': 'Overall survival: defined as the time between the first cycle of chemotherapy and the date of death, all causes. In the absence of death confirmation, survival data are censored from the date of last news'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Upper aero-digestive tract tumours', 'FCGR3A and FCGR2A receptor polymorphism', 'Cetuximab efficacy'], 'conditions': ['Upper Gingival Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Hypothesis:\n\nCetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.\n\nThe investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.', 'detailedDescription': 'Hypothesis:\n\nCetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.\n\nWe therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.\n\nThis study is a multicentre prospective pharmacogenetic observational study, conducted on locally advanced and inoperable upper aerodigestive tract cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Squamous cell carcinomas of the upper aero-digestive tract recurrent or metastatic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract\n* Patient with loco-regional extension not readily treatable\n* 18 years\n* Follow up in participant center\n* Patient information and consent for study participation\n* Patient presented in multidisciplinary meeting (RCP) in Aquitaine and for whom a treatment containing cetuximab has been proposed\n* Belong to a social security system\n\nExclusion Criteria:\n\n* Pregnancy\n* Patient with psychological, social, family or geographical reason, who could not be treated or monitored regularly by study criteria,\n* Patients deprived of liberty or under guardianship or who could not give consent for study participation\n* Inclusion in another study'}, 'identificationModule': {'nctId': 'NCT01827956', 'acronym': 'FCRVADS', 'briefTitle': 'Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours', 'orgStudyIdInfo': {'id': 'IB2009-24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blood sample', 'description': 'Blood sample for identifying the polymorphism', 'interventionNames': ['Other: Blood sample for identifying the polymorphism']}], 'interventions': [{'name': 'Blood sample for identifying the polymorphism', 'type': 'OTHER', 'description': 'Blood sample for identifying the polymorphism', 'armGroupLabels': ['Blood sample']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'state': 'Aquitaine', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'ROBERT Jacques, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Bergonié'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-27', 'type': 'RELEASE'}, {'date': '2025-09-15', 'type': 'RESET'}, {'date': '2025-09-16', 'type': 'RELEASE'}, {'date': '2025-10-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Institut Bergonié'}}}}