Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT01689194
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2012-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2012-08-30', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate', 'timeFrame': 'every 2 cycles, 6wk later after chemotherapy', 'description': 'RECIST'}], 'secondaryOutcomes': [{'measure': 'Locoregional control rate', 'timeFrame': 'every 3wk (every cycle)', 'description': 'NCI CTCAE'}, {'measure': 'Quality of life', 'timeFrame': 'every 3wk (every cycle)', 'description': 'EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)'}, {'measure': 'safety', 'timeFrame': 'every 3wk (every cycle)', 'description': 'NCI CTCAE v3.0; disease or syndrome, pathologic funtion, sign or symptom, imjury or poisoning, anatomical abnormality, mental or behavioral dysfunction Neutropenia, leucopenia, thrombocytopenia, hepatotoxicity, renal toxicity'}]}, 'conditionsModule': {'conditions': ['Locally Advanced Head and Neck Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '30796155', 'type': 'DERIVED', 'citation': 'Keam B, Lee KW, Lee SH, Kim JS, Kim JH, Wu HG, Eom KY, Kim S, Ahn SH, Chung EJ, Kwon SK, Jeong WJ, Jung YH, Kim JW, Heo DS. A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma. Oncologist. 2019 Jun;24(6):751-e231. doi: 10.1634/theoncologist.2019-0070. Epub 2019 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* locally advanced head and neck squamous cell carcinoma\n* oral cavity, oropharynx, hypopharynx, larynx\n* measurable lesion\n* unresectable\n* age 18 or more\n* ECOG 0 or 1\n\nExclusion Criteria:\n\n* distant metastasis\n* pregnancy\n* prior chemotherapy or radiation therapy\n* 2ndary malignancy\n* other unfit medical condition'}, 'identificationModule': {'nctId': 'NCT01689194', 'briefTitle': 'Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)', 'orgStudyIdInfo': {'id': 'CRCST-L-0007'}, 'secondaryIdInfos': [{'id': 'H-1204-103-407', 'type': 'OTHER', 'domain': 'SNUH IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'genexolPM + cisplatin', 'interventionNames': ['Drug: genexolPM + cisplatin']}], 'interventions': [{'name': 'genexolPM + cisplatin', 'type': 'DRUG', 'armGroupLabels': ['genexolPM + cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Se-Hoon Lee, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, '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': 'Se-Hoon Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}