Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT01280318
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2011-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-13', 'studyFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2011-01-19', 'lastUpdatePostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'identification of the biomarkers could lead to the development of peri-operative targeted therapies to decrease the risk of local and distant tumor growth', 'timeFrame': '5 months'}], 'secondaryOutcomes': [{'measure': 'Compare the results of group I with groups II and III', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Head and Neck Squamous Cell Carcinoma', 'Growth Factor', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and over\n\n \\_ histological proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharinx or larynx\n* Patients selected for a primary surgical treatment\n* no distant metastases\n* no active second malignancy during the last 5 years except non melanoma skin cancer or carcinoma in situ of the cervix\n* no prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery\n* life expectancy of more than 3 months\n* not pregnant or nursing; fertile patients both male and female, must use effective contraception\n* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n* signed informed consent\n* performance status ECOG 0-1\n\nExclusion Criteria:\n\n* Nasopharynx cancer\n* past or current malignancy other than HNSCC\n* performance ECOG status more than 2\n* concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol\n* use of any investigational agents within 4 weeks prior to entry\n* Previous exposure to EGFR targeting therapy\n* known grade hypersensitivity to cetuximab\n* legal incapacity or limited legal capacity or medical or psychological condition which in the opiniion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.'}, 'identificationModule': {'nctId': 'NCT01280318', 'acronym': 'HNSCC', 'briefTitle': 'Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery', 'orgStudyIdInfo': {'id': 'UCL-ONCO 2008-03'}, 'secondaryIdInfos': [{'id': 'Academic study'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'patients with operable head and neck squamous cell carcinoma', 'interventionNames': ['Procedure: head and neck surgery']}, {'type': 'OTHER', 'label': '2', 'description': 'patients treated by neck ansd head surgery for a non-oncological disease', 'interventionNames': ['Procedure: head and neck surgery']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'patients treated before surgery with 3 doses of neoadjuvant cetuximab', 'interventionNames': ['Procedure: head and neck surgery']}], 'interventions': [{'name': 'head and neck surgery', 'type': 'PROCEDURE', 'description': 'Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Jean-Pascal Machiels', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Jean-Pascal Machiels, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques Universitaires St Luc-UCL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}