Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 11:15 AM
Study NCT ID:
NCT01312350
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2011-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007012', 'term': 'Hypopharyngeal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C095424', 'term': 'CF regimen'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2011-02-21', 'studyFirstSubmitQcDate': '2011-03-08', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only', 'timeFrame': '18 months after the enrollment of the last patients'}], 'secondaryOutcomes': [{'measure': 'To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only', 'timeFrame': '18 months after enrollemnt of last patients'}, {'measure': 'To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only', 'timeFrame': '18 months after the enrollment of the last patient'}, {'measure': 'To determine whether addition of neoadjuvant chemotherapy to CCRT increase the number of patients with adverse events compared with CCRT only', 'timeFrame': '18 months after the enrollment of the last patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neoadjuvant chemotherapy', 'definitive chemoradiation therapy', 'head and neck cancer', 'base of tongue', 'Locally advanced'], 'conditions': ['Hypopharyngeal Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III \\& IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically/cytologically proven stage III/IVM0 hypopharyngeal or base of tongue cancer\n* One or more evaluable or measurable lesion\n* No prior chemotherapy, radiation, or surgery\n* ECOG 0-2\n\nExclusion Criteria:\n\n* Distant metastasis\n* Other malignancy'}, 'identificationModule': {'nctId': 'NCT01312350', 'briefTitle': 'Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Concurrent Chemoradiation Versus Induction Docetaxel, Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy in Locally Advanced Hypopharyngeal and Base of Tongue Cancer: A Randomized Phase II Study', 'orgStudyIdInfo': {'id': '2010-10-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CCRT only arm', 'description': 'no neoadjuvant chemotherapy before definitive CCRT', 'interventionNames': ['Drug: No treatment before definitive CCRT']}, {'type': 'EXPERIMENTAL', 'label': 'neoadjuvant chemotherapy arm', 'description': '2 cycles of TPF chemotherapy before definitive CCRT', 'interventionNames': ['Drug: neoadjuvant docetaxel/cisplatin/fluorouracil']}], 'interventions': [{'name': 'neoadjuvant docetaxel/cisplatin/fluorouracil', 'type': 'DRUG', 'otherNames': ['Docetaxel (taxotere)'], 'description': '2 cycles of neoadjuvant Docetaxel/cisplatin/5-fluorouracil therapy followed by CCRT Neoadjuvant chemotherapy (docetaxel 75mg/m2 D1, cisplatin 75mg/m2 D1, 5-fluoruracil 759mg/m2/day, D1-4, every 3 weeks) CCRT protocol is same with that of control arm.', 'armGroupLabels': ['neoadjuvant chemotherapy arm']}, {'name': 'No treatment before definitive CCRT', 'type': 'DRUG', 'description': 'concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43', 'armGroupLabels': ['CCRT only arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Keunchil Park', 'investigatorAffiliation': 'Samsung Medical Center'}}}}