Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-31 @ 1:14 AM
Study NCT ID:
NCT01344356
Status:
COMPLETED
Last Update Posted:
2020-04-10
First Post:
2011-04-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Body Radiotherapy for Head and Neck Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], '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': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michelle.bryant@mercy.net', 'phone': '314-251-8827', 'title': 'Mercy Research Manager - Regulatory Operations', 'organization': 'Mercy Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 years', 'description': 'Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0', 'eventGroups': [{'id': 'EG000', 'title': 'Benign Tumors', 'description': 'Benign head and neck tumors will be treated with SBRT\n\nstereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Malignant Tumors', 'description': 'Malignant Head and Neck Tumors will be treated with SBRT.\n\nStereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hoarseness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cranial Nerve Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Local Control Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Benign Tumors', 'description': 'Benign head and neck tumors will be treated with SBRT\n\nstereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)'}, {'id': 'OG001', 'title': 'Malignant Tumors', 'description': 'Malignant Head and Neck Tumors will be treated with SBRT.\n\nStereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Complete or partial tumor response or stable disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '12 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.'}, {'type': 'PRIMARY', 'title': 'Local Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Benign Tumors', 'description': 'Benign head and neck tumors will be treated with SBRT\n\nstereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)'}, {'id': 'OG001', 'title': 'Malignant Tumors', 'description': 'Malignant Head and Neck Tumors will be treated with SBRT.\n\nStereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Instances of progressive disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '12 patients did not have local recurrence rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.'}, {'type': 'PRIMARY', 'title': 'Complication Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Benign Tumors', 'description': 'Benign head and neck tumors will be treated with Stereotactic body radiotherapy\n\nstereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)'}, {'id': 'OG001', 'title': 'Unrescectable Malignant Tumors', 'description': 'Malignant Head and Neck Tumors will be treated with Stereotactic body radiotherapy.\n\nStereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Number of participants with any adverse event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Benign Tumors', 'description': 'Benign head and neck tumors will be treated with SBRT\n\nstereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)'}, {'id': 'OG001', 'title': 'Malignant Tumors', 'description': 'Malignant Head and Neck Tumors will be treated with SBRT.\n\nStereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Number of participants who are alive 5 years following treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '9 patients did not have overall survival data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Benign Tumors', 'description': 'Benign head and neck tumors will be treated with stereotactic body radiation therapy\n\nstereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)'}, {'id': 'FG001', 'title': 'Unrescectable Malignant Tumors', 'description': 'Malignant Head and Neck Tumors will be treated with stereotactic body radiation therapy.\n\nStereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Benign Tumors', 'description': 'Benign head and neck tumors will be treated with SBRT\n\nstereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)'}, {'id': 'BG001', 'title': 'Unrescectable Malignant Tumors', 'description': 'Malignant Head and Neck Tumors will be treated with SBRT.\n\nStereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2013-02-04', 'size': 385829, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-18T13:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-28', 'studyFirstSubmitDate': '2011-04-27', 'resultsFirstSubmitDate': '2020-02-28', 'studyFirstSubmitQcDate': '2011-04-27', 'lastUpdatePostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-28', 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Control Rate', 'timeFrame': '5 years', 'description': 'Complete or partial tumor response or stable disease'}, {'measure': 'Local Recurrence', 'timeFrame': '5 years', 'description': 'Instances of progressive disease'}, {'measure': 'Complication Rate', 'timeFrame': '5 years', 'description': 'Number of participants with any adverse event'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'Number of participants who are alive 5 years following treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stereotactic radiosurgery', 'head and neck tumors', 'squamous cell carcinoma of head and neck'], 'conditions': ['Squamous Cell Carcinoma of the Head and Neck', 'Nasopharyngeal Carcinoma', 'Salivary Gland Cancer', 'Head and Neck Sarcoma', 'Paraganglioma of Head and Neck', 'Chordoma of Head and Neck', 'Chondrosarcoma of Head and Neck', 'Angiofibroma of Head and Neck']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.', 'detailedDescription': "This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:\n\n* Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection\n* Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group)\n* Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities.\n\nFollow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age \\> 18 years\n* Zubrod performance status of 0-3\n* Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma\n* Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma\n* Signed study-specific consent form\n\nExclusion Criteria:\n\n* Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females\n* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent'}, 'identificationModule': {'nctId': 'NCT01344356', 'briefTitle': 'Stereotactic Body Radiotherapy for Head and Neck Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Research'}, 'officialTitle': 'Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors', 'orgStudyIdInfo': {'id': '08-046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Benign Tumors', 'description': 'Benign head and neck tumors will be treated with SBRT', 'interventionNames': ['Radiation: stereotactic body radiotherapy']}, {'type': 'OTHER', 'label': 'Malignant Tumors', 'description': 'Malignant Head and Neck Tumors will be treated with SBRT.', 'interventionNames': ['Radiation: Stereotactic body radiotherapy']}], 'interventions': [{'name': 'stereotactic body radiotherapy', 'type': 'RADIATION', 'description': '14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)', 'armGroupLabels': ['Benign Tumors']}, {'name': 'Stereotactic body radiotherapy', 'type': 'RADIATION', 'description': '8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)', 'armGroupLabels': ['Malignant Tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Mercy Medical Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Robert Frazier, MD', 'investigatorAffiliation': 'Mercy Research'}}}}