Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT00462735
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2007-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D009669', 'term': 'Nose Neoplasms'}, {'id': 'D010255', 'term': 'Paranasal Sinus Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D012888', 'term': 'Skull Neoplasms'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D006918', 'term': 'Hydroxyurea'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'johnnykaomd@gmail.com', 'phone': '813-661-6442', 'title': 'Dr. Johnny Kao', 'organization': 'Florida Radiation Oncology Group'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Advanced Head and Neck Cancer', 'description': 'Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck', 'otherNumAtRisk': 33, 'otherNumAffected': 33, 'seriousNumAtRisk': 33, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Xerostomia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Low Absolute neutrophil count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Low White blood count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Low Hemoglobin count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Low Platelet count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}], 'seriousEvents': [{'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Low Absolute neutrophil count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Low White blood count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Low Hemoglobin count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}, {'term': 'Low Platelets count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE 3.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Llocoregional Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced Head and Neck Cancer', 'description': 'Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Percentage of Participants with Loco-regional recurrence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced Head and Neck Cancer', 'description': 'Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.'}], 'classes': [{'title': 'Overall Survival', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Disease-Free Survival', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Overall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Long- Term Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced Head and Neck Cancer', 'description': 'Cetuximab - 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Grade 3 toxicities events', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'UW-QOLR: Quality of Life Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced Head and Neck Cancer', 'description': 'Cetuximab - 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'University of Washington Quality of Life (UW-QOLR) questionnaire - covers 12 domains - pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety. Each domain have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response and reported as one composite score from 0 (worst) to 100 (best).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty patients completed the UW-QOLR questionnaire before and after therapy.'}, {'type': 'SECONDARY', 'title': 'Distant Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced Head and Neck Cancer', 'description': 'Cetuximab - 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Percentage of participants who did not have distant control', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Advanced Head and Neck Cancer', 'description': 'Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck. Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.\n\nRadiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.\n\nRadiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period January 2007 through April 2008. All cases were reviewed at a multidisciplinary conference, which was attended by representatives from the Departments of Head and Neck Surgery, Radiation Oncology, Medical Oncology, Palliative Care, Social Work, and Nutrition at Icahn School of Medicine at Mount Sinai.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Advanced Head and Neck Cancer', 'description': 'Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Performance score', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The Eastern Cooperative Oncology Group (ECOG)\n\n0 - Fully active, able to carry on all pre-disease performance without restriction\n\n1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours', 'unitOfMeasure': 'participants'}, {'title': 'Charlson comorbidity score', 'classes': [{'title': '0-1', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': '≥2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The Charlson Comorbidity Index contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions. Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality. Higher scores indicating greater comorbidity (patients with a score \\> 5 have essentially a 100% risk of dying at one year).', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol consumption', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Occasional', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Heavy', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Cigar, pipe, or betel nut only', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '≤20 pack-y', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': '20.1-40 packk-y', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '>40 pack-y', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary site', 'classes': [{'title': 'Sinonasal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Nasopharynx', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Oropharynx', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Oral cavity', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Salivary gland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Larynx', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Hyopharynx', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Unknown primary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-13', 'studyFirstSubmitDate': '2007-04-18', 'resultsFirstSubmitDate': '2016-12-23', 'studyFirstSubmitQcDate': '2007-04-18', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-13', 'studyFirstPostDateStruct': {'date': '2007-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Llocoregional Recurrence', 'timeFrame': '2 years', 'description': 'Percentage of Participants with Loco-regional recurrence.'}, {'measure': 'Survival', 'timeFrame': '2 years', 'description': 'Overall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology'}], 'secondaryOutcomes': [{'measure': 'Long- Term Toxicity', 'timeFrame': '2 years', 'description': 'Grade 3 toxicities events'}, {'measure': 'UW-QOLR: Quality of Life Score', 'timeFrame': '2 years', 'description': 'University of Washington Quality of Life (UW-QOLR) questionnaire - covers 12 domains - pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety. Each domain have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response and reported as one composite score from 0 (worst) to 100 (best).'}, {'measure': 'Distant Metastases', 'timeFrame': '2 years', 'description': 'Percentage of participants who did not have distant control'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer of the Nasal Cavity'], 'conditions': ['Head and Neck Cancer', 'Cancer of the Pharynx', 'Cancer of the Larynx', 'Nose Neoplasms', 'Paranasal Sinus Neoplasms', 'Cancer of the Oral Cavity']}, 'referencesModule': {'references': [{'pmid': '20830768', 'type': 'RESULT', 'citation': 'Kao J, Genden EM, Gupta V, Policarpio EL, Burri RJ, Rivera M, Gurudutt V, Som PM, Teng M, Packer SH. Phase 2 trial of concurrent 5-fluorouracil, hydroxyurea, cetuximab, and hyperfractionated intensity-modulated radiation therapy for locally advanced head and neck cancer. Cancer. 2011 Jan 15;117(2):318-26. doi: 10.1002/cncr.25374. Epub 2010 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck or lymphoepithelioma\n* No prior chemotherapy or radiotherapy\n* Prior surgical therapy will consist only of incisional or excisional biopsy, and organ sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an existing primary tumor\n* Karnofsky performance status of \\>= 70%\n* Intact organ and bone marrow function\n* Obtained informed consent\n\nExclusion Criteria:\n\n* Demonstration of metastatic disease (i.e. M1 disease).\n* Patients with a history of severe allergic reaction to docetaxel or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or hydroxyurea.\n* Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical cancer in situ, and other treated malignancies with no evidence of disease for at least 3 years.\n* Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor. Any non-biopsy procedure must have taken place less than 3 months from initiating protocol treatment.\n* Incomplete healing from previous surgery\n* Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician.\n* Uncontrolled active infection unless curable with treatment of their cancer.'}, 'identificationModule': {'nctId': 'NCT00462735', 'briefTitle': 'Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'GCO 06-1155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advanced Head and Neck Cancer', 'description': 'Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck', 'interventionNames': ['Drug: Cetuximab', 'Drug: Hydroxyurea', 'Drug: Fluorouracil', 'Procedure: radiotherapy']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'description': '250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients', 'armGroupLabels': ['Advanced Head and Neck Cancer']}, {'name': 'Hydroxyurea', 'type': 'DRUG', 'description': '500 mg orally every 12 hours with the morning dose administered 2 hours before radiation', 'armGroupLabels': ['Advanced Head and Neck Cancer']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'description': 'continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours', 'armGroupLabels': ['Advanced Head and Neck Cancer']}, {'name': 'radiotherapy', 'type': 'PROCEDURE', 'description': 'Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.\n\nRadiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients.', 'armGroupLabels': ['Advanced Head and Neck Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Johnny Kao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnny Kao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Johnny Kao', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}