Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-01-17 @ 2:15 PM
Study NCT ID:
NCT01891695
Status:
TERMINATED
Last Update Posted:
2022-10-12
First Post:
2013-06-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OPSCC N0 Nodal Control With Reduced IMRT
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': 'D030361', 'term': 'Papillomavirus Infections'}], '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'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pwr3u@hscmail.mcc.virginia.edu', 'phone': '434-924-5191', 'title': 'Paul Read, MD', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Reduced Intensity Radiation', 'description': '39.6 Gy radiation to clinically uninvolved cervical lymphatics\n\n39.6 Gy radiation', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspahgiz', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngeal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WBC decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestine obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'N0 Nodal Control Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Intensity Radiation', 'description': '39.6 Gy radiation to clinically uninvolved cervical lymphatics\n\n39.6 Gy radiation'}], 'timeFrame': 'Up to 3 years post treatment', 'description': 'Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA)', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was stopped prematurely after 1 subject was enrolled. No analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Intensity Radiation', 'description': '39.6 Gy radiation to clinically uninvolved cervical lymphatics\n\n39.6 Gy radiation'}], 'timeFrame': 'Up to 3 years post treatment', 'description': 'Evaluated safety and tolerability of treatment of p16+ OPSCCA by overall incidence of adverse events, incidence of acute and late toxicities and subject-rated quality of life assessments.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated after one subject enrolled. No analysis performed.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Intensity Radiation', 'description': '39.6 Gy radiation to clinically uninvolved cervical lymphatics\n\n39.6 Gy radiation'}], 'timeFrame': 'Up to 3 years post treatment', 'description': 'Patient status reviewed and confirmed through Neck CT and PET scans at follow up time points throughout trial', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis performed. Study was terminated after one subject was enrolled.'}, {'type': 'SECONDARY', 'title': 'Dose Volume Histograms (DVH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Intensity Radiation', 'description': '39.6 Gy radiation to clinically uninvolved cervical lymphatics\n\n39.6 Gy radiation'}], 'timeFrame': 'Up to 3 years post treatment', 'description': 'Comparison of DVH of treatment plans between patients receiving 39.6 Gy versus the standard dose of 50 Gy to the clinically uninvolved neck', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was halted early. Only one subject was enrolled. No analysis performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reduced Intensity Radiation', 'description': '39.6 Gy radiation to clinically uninvolved cervical lymphatics\n\n39.6 Gy radiation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Reduced Intensity Radiation', 'description': '39.6 Gy radiation to clinically uninvolved cervical lymphatics\n\n39.6 Gy radiation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-04-09', 'size': 905496, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-09T10:52', 'hasProtocol': True}, {'date': '2013-06-03', 'size': 849832, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-06-09T10:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Study had very specific inclusion/exclusion criteria and difficult to recruit', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-20', 'studyFirstSubmitDate': '2013-06-24', 'resultsFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2013-06-28', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-20', 'studyFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'N0 Nodal Control Rate', 'timeFrame': 'Up to 3 years post treatment', 'description': 'Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA)'}], 'secondaryOutcomes': [{'measure': 'Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck', 'timeFrame': 'Up to 3 years post treatment', 'description': 'Evaluated safety and tolerability of treatment of p16+ OPSCCA by overall incidence of adverse events, incidence of acute and late toxicities and subject-rated quality of life assessments.'}, {'measure': 'Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck', 'timeFrame': 'Up to 3 years post treatment', 'description': 'Patient status reviewed and confirmed through Neck CT and PET scans at follow up time points throughout trial'}, {'measure': 'Dose Volume Histograms (DVH)', 'timeFrame': 'Up to 3 years post treatment', 'description': 'Comparison of DVH of treatment plans between patients receiving 39.6 Gy versus the standard dose of 50 Gy to the clinically uninvolved neck'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Oropharyngeal Squamous Cell Carcinoma (OPSCCA)', 'HPV (Human Papillomavirus)-Associated']}, 'descriptionModule': {'briefSummary': 'The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering.\n\nThe purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.', 'detailedDescription': 'A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient must be clinically referred for radiation for stage I-IVb OPSCCA\n* tumor must be HPV-associated p16+\n* patient must be able to lie flat and tolerate immobilization systems\n\nExclusion Criteria:\n\n* patients may not be receiving any investigational agents\n* prior radiation to head and neck\n* any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years\n* any major medical, psychiatric, or neurologic illness\n* pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT01891695', 'briefTitle': 'OPSCC N0 Nodal Control With Reduced IMRT', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx', 'orgStudyIdInfo': {'id': '16766'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced Intensity Radiation', 'description': '39.6 Gy radiation to clinically uninvolved cervical lymphatics', 'interventionNames': ['Radiation: 39.6 Gy radiation']}], 'interventions': [{'name': '39.6 Gy radiation', 'type': 'RADIATION', 'armGroupLabels': ['Reduced Intensity Radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Paul W Read, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paul W. Read, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Paul W. Read, MD', 'investigatorAffiliation': 'University of Virginia'}}}}