Viewing Study NCT01111058

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Ignite Creation Date: 2025-12-24 @ 11:58 PM
Ignite Modification Date: 2025-12-25 @ 9:56 PM
Study NCT ID: NCT01111058
Status: TERMINATED
Last Update Posted: 2020-04-07
First Post: 2010-04-23
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Everolimus Versus Placebo in Head and Neck Cancer
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'evokes@medicine.bsd.uchicago.edu', 'phone': '(773) 702-9306', 'title': 'Everett Vokes, MD', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 years', 'eventGroups': [{'id': 'EG000', 'title': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily\n\nEverolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 25, 'seriousNumAtRisk': 28, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects will receive double-blind placebo\n\nPlacebo', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 14, 'seriousNumAtRisk': 24, 'deathsNumAffected': 4, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cholesterol high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Investigations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Papulopustular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin and subcutaneous tissue disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Leukemia secondary to oncology chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '2 Year Progression Free Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily\n\nEverolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive double-blind placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '81.2'}, {'value': '55.9', 'groupId': 'OG001', 'lowerLimit': '34.1', 'upperLimit': '77.8'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in survival proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0022', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.33', 'statisticalMethod': 'Comparison of Kaplan-Meier estimates', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Used Greenwood standard errors'}, {'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Time to disease progression or death from any cause--2 year rate', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily\n\nEverolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive double-blind placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.086', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Adverse event rate, any type, any grade regardless of attribution', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Site of Progression: Local-regional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily\n\nEverolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive double-blind placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Number of patients with local-regional progression', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Site of Progression: Distant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily\n\nEverolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive double-blind placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Number of patients with distant progression', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Site of Progression: Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily\n\nEverolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive double-blind placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Number of patients with unknown site of progression', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Second Primary Tumor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily\n\nEverolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive double-blind placebo\n\nPlacebo'}], 'timeFrame': '4 years', 'description': 'Number of patients with second primary tumor', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not systematically recorded.'}, {'type': 'SECONDARY', 'title': 'Akt/mTOR Pathway Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily\n\nEverolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive double-blind placebo\n\nPlacebo'}], 'timeFrame': 'Baseline', 'description': 'mTOR positive in tumor tissue', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Correlation of Akt/mTOR Status With Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily\n\nEverolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive double-blind placebo\n\nPlacebo'}], 'timeFrame': '4 years', 'description': 'mTOR positive in tumor tissue', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Determine if PTEN Status is a Predictive Biomarker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 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receive double-blind placebo\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily\n\nEverolimus (RAD 001): 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects will receive double-blind placebo\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '71'}, {'value': '57.4', 'groupId': 'BG001', 'lowerLimit': '37', 'upperLimit': '76'}, {'value': '57.7', 'groupId': 'BG002', 'lowerLimit': '37', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 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'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-02-14', 'size': 349691, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-03T11:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2010-04-23', 'resultsFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-25', 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2 Year Progression Free Survival Rate', 'timeFrame': '2 years', 'description': 'Time to disease progression or death from any cause--2 year rate'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Toxicity', 'timeFrame': '4 years', 'description': 'Adverse event rate, any type, any grade regardless of attribution'}, {'measure': 'Site of Progression: Local-regional', 'timeFrame': '4 years', 'description': 'Number of patients with local-regional progression'}, {'measure': 'Site of Progression: Distant', 'timeFrame': '4 years', 'description': 'Number of patients with distant progression'}, {'measure': 'Site of Progression: Unknown', 'timeFrame': '4 years', 'description': 'Number of patients with unknown site of progression'}, {'measure': 'Second Primary Tumor', 'timeFrame': '4 years', 'description': 'Number of patients with second primary tumor'}, {'measure': 'Akt/mTOR Pathway Activation', 'timeFrame': 'Baseline', 'description': 'mTOR positive in tumor tissue'}, {'measure': 'Correlation of Akt/mTOR Status With Progression-free Survival', 'timeFrame': '4 years', 'description': 'mTOR positive in tumor tissue'}, {'measure': 'Determine if PTEN Status is a Predictive Biomarker', 'timeFrame': '4 years', 'description': 'Differential effect of PTEN status on progression-free survival between the two arms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Squamous Cell Cancer'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '36194164', 'type': 'DERIVED', 'citation': "Nathan CO, Hayes DN, Karrison T, Harismendy O, Flores JM, Moore-Medlin T, Vokes EE, Gutkind JS, Neupane P, Mills G, Sargi Z, Seiwert T, Grilley-Olson J, Day T, Gillison M, Wade JL, Feldman L, Jha G, Kozloff M, O'Leary M, Worden FP, Cohen EEW. A Randomized Multi-institutional Phase II Trial of Everolimus as Adjuvant Therapy in Patients with Locally Advanced Squamous Cell Cancer of the Head and Neck. Clin Cancer Res. 2022 Dec 1;28(23):5040-5048. doi: 10.1158/1078-0432.CCR-21-4290."}], 'seeAlsoLinks': [{'url': 'http://uccrc.uchicago.edu/', 'label': 'The University of Chicago Comprehensive Cancer Center Web Page'}]}, 'descriptionModule': {'briefSummary': 'Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Squamous cell carcinoma of the head and neck (stage IVa or IVb). No evidence (absence)of disease by scan.\n* 18 years or older.\n* Performance status 70% or better.\n* Adequate marrow, renal and liver function (will be tested by labs). \\_ Able give consent.\n\nExclusion Criteria:\n\n* Currently receiving anti-cancer treatment.\n* Major surgery or traumatic injury within 4 weeks.\n* Radiotherapy related toxicities.\n* Lip, nasopharynx, nasal cavity, paranasal sinus, salivary gland, skin, or thyroid primary tumors\n* Receiving other investigational drugs.\n* Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.\n* Receive immunization with attenuated live vaccines (seasonal flu shot)1 week before starting this .\n* Show evidence of disease (cancer).\n* Uncontrolled medical conditions such as: unstable angina, congestive heart failure, diabetes, severely impaired lung function.\n* Liver disease such as cirrhosis, severe hepatic impairment, Hepatitis B or C.\n* Active, uncontrolled severe infections\n* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.\n* Known History of HIV positivity.\n* Impaired gastrointestinal function that may alter absorption of Everolimus such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection.\n* Patients with an active, bleeding diathesis.\n* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. )\n* Male patient whose sexual partner(s) are Women of child bearing potential who are not willing to use adequate.\n\ncontraception, during the study and for 8 weeks after the end of treatment\n\n* Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).\n* Patients with a known hypersensitivity to Everolimus or other rapamycin analogues (sirolimus, temsirolimus) or to its excipients.\n* History of noncompliance to medical regimens.\n* Patients unwilling to or unable to comply with the protocol.'}, 'identificationModule': {'nctId': 'NCT01111058', 'briefTitle': 'Everolimus Versus Placebo in Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Randomized Phase II Trial of Everolimus Versus Placebo as Adjuvant Therapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)', 'orgStudyIdInfo': {'id': '09-266-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus (RAD001)', 'description': 'Subjects will receive Everolimus 10 mg daily', 'interventionNames': ['Drug: Everolimus (RAD 001)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Subjects will receive double-blind placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Everolimus (RAD 001)', 'type': 'DRUG', 'description': '10mg of 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'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina Hollings Cancer Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Medical Branch at Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Tanguy Seiwert, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Chicago Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}