Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-04-23 @ 12:50 AM
Study NCT ID:
NCT02110992
Status:
TERMINATED
Last Update Posted:
2019-11-25
First Post:
2014-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D016634', 'term': 'Radiosurgery'}, {'id': 'D011878', 'term': 'Radiotherapy'}], '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'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of acute dose limiting toxicities', 'timeFrame': '3 months', 'description': 'Acute dose limiting toxicity is defined as grade 4 or 5 toxicity measured by the Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0, including carotid arterial rupture'}], 'secondaryOutcomes': [{'measure': 'Locoregional control', 'timeFrame': '2 years', 'description': 'Time from enrollment until local failure or death (whichever comes first)'}, {'measure': 'Disease-free survival', 'timeFrame': '2 years', 'description': 'Time from enrollment until disease progression anywhere in the body or death (whichever comes first)'}, {'measure': 'overall survival', 'timeFrame': '2 years', 'description': 'Time from enrollment to death from any cause'}, {'measure': 'Number of late effect dose limiting toxicities', 'timeFrame': '2 years', 'description': 'Occuring \\> 3 months after treatment completion, including grade 4 and 5 toxicities measured by CTCAE v 4.0 involving skin, mucosa, larynx, pharynx, spinal cord, cranial nerves, and incidence of caroid blowout.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent or second primary squamous cell head and neck cancer\n* Defined area of recurrence on imaging\n* Previous head and neck radiation (RT) to \\>/= 50 Gy\n* Performance status score 0-1\n* Time interval from previous RT \\>/= 9 months\n* Volume of disease appropriate for protocol treatment\n* Minimum estimated survival of \\>/= 3 months\n* Age \\>/= 18\n* Adequate labs\n\nExclusion Criteria:\n\n* Primary tumors of the salivary gland\n* Original pathology report and radiation therapy records not available\n* Prior spinal cord dose \\> 45 Gy\n* Surgery or chemotherapy within 4 weeks\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted'}, 'identificationModule': {'nctId': 'NCT02110992', 'briefTitle': 'Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'A Phase I Pilot Study of SBRT and Concurrent Docetaxel for Reirradiation of Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'UCCI-HN-13-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docetaxel + Stereotactic Radiation', 'description': 'Docetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by \\> 48 hours.', 'interventionNames': ['Drug: Docetaxel', 'Radiation: Stereotactic Radiation']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere', 'NDC 0075-8001-20'], 'description': 'Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT', 'armGroupLabels': ['Docetaxel + Stereotactic Radiation']}, {'name': 'Stereotactic Radiation', 'type': 'RADIATION', 'otherNames': ['SBRT', 'Stereotactic Body Radiation', 'Radiation Therapy'], 'description': 'SBRT will be given over 5 fractions separated by \\> 48 hours. Dose will be determined based upon dose escalation schedule and will range from 25-40 Gy.', 'armGroupLabels': ['Docetaxel + Stereotactic Radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267-0502', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Cancer Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Brad Huth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}