Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-06 @ 3:10 AM
Study NCT ID:
NCT00468169
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2007-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally 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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D006918', 'term': 'Hydroxyurea'}, {'id': 'D002945', 'term': 'Cisplatin'}], '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': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'evokes@medicine.bsd.uchicago.edu', 'phone': '(773) 702-9306', 'title': 'Everett E Vokes, MD', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 months', 'eventGroups': [{'id': 'EG000', 'title': 'A: Cetuximab+FHX', 'description': 'Cetuximab \\[250mg/m2 (day 1, weekly x10)\\] + FHX (5-FU \\[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\\], Hydroxyurea \\[500 mg PO BID, days 0-5 (=11 doses), every other week x5\\] and twice-daily radiation \\[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\\]). Total duration is 10 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 57, 'seriousNumAtRisk': 57, 'deathsNumAffected': 14, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'B: Cetuximab + PX', 'description': 'Cetuximab \\[250 mg/m2 (day 1, weekly x7)\\] + PX (Cisplatin \\[100mg/m2 (week 1 \\& 4 on day 1 (or 2))\\], Accelerated fraction radiotherapy with concomitant boost \\[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\\]). Total duration: 7 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 53, 'seriousNumAtRisk': 53, 'deathsNumAffected': 9, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 37}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 45}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 36}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 47}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 53}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nervous system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 39}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 49}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 53}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 49}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'G-tube placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Malnourished', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Presyncopal episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Cetuximab+FHX', 'description': 'Cetuximab \\[250mg/m2 (day 1, weekly x10)\\] + FHX (5-FU \\[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\\], Hydroxyurea \\[500 mg PO BID, days 0-5 (=11 doses), every other week x5\\] and twice-daily radiation \\[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\\]). Total duration is 10 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}, {'id': 'OG001', 'title': 'B: Cetuximab + PX', 'description': 'Cetuximab \\[250 mg/m2 (day 1, weekly x7)\\] + PX (Cisplatin \\[100mg/m2 (week 1 \\& 4 on day 1 (or 2))\\], Accelerated fraction radiotherapy with concomitant boost \\[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\\]). Total duration: 7 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}], 'classes': [{'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '76.0', 'upperLimit': '94.0'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '81.1', 'upperLimit': '97.1'}]}]}], 'analyses': [{'pValue': '0.1225', 'groupIds': ['OG000'], 'pValueComment': 'Log-rank test comparing PFS between two treatment arms', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '1 years', 'description': 'Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'unitOfMeasure': 'Probability (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Cetuximab+FHX', 'description': 'Cetuximab \\[250mg/m2 (day 1, weekly x10)\\] + FHX (5-FU \\[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\\], Hydroxyurea \\[500 mg PO BID, days 0-5 (=11 doses), every other week x5\\] and twice-daily radiation \\[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\\]). Total duration is 10 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}, {'id': 'OG001', 'title': 'B: Cetuximab + PX', 'description': 'Cetuximab \\[250 mg/m2 (day 1, weekly x7)\\] + PX (Cisplatin \\[100mg/m2 (week 1 \\& 4 on day 1 (or 2))\\], Accelerated fraction radiotherapy with concomitant boost \\[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\\]). Total duration: 7 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}], 'classes': [{'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000', 'lowerLimit': '71.9', 'upperLimit': '91.5'}, {'value': '84.9', 'groupId': 'OG001', 'lowerLimit': '72.1', 'upperLimit': '92.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'unitOfMeasure': 'Probability (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Cetuximab+FHX', 'description': 'Cetuximab \\[250mg/m2 (day 1, weekly x10)\\] + FHX (5-FU \\[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\\], Hydroxyurea \\[500 mg PO BID, days 0-5 (=11 doses), every other week x5\\] and twice-daily radiation \\[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\\]). Total duration is 10 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}, {'id': 'OG001', 'title': 'B: Cetuximab + PX', 'description': 'Cetuximab \\[250 mg/m2 (day 1, weekly x7)\\] + PX (Cisplatin \\[100mg/m2 (week 1 \\& 4 on day 1 (or 2))\\], Accelerated fraction radiotherapy with concomitant boost \\[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\\]). Total duration: 7 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}], 'classes': [{'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000', 'lowerLimit': '80.2', 'upperLimit': '96.3'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '83.5', 'upperLimit': '98.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.', 'unitOfMeasure': 'Probability (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate to Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Cetuximab+FHX', 'description': 'Cetuximab \\[250mg/m2 (day 1, weekly x10)\\] + FHX (5-FU \\[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\\], Hydroxyurea \\[500 mg PO BID, days 0-5 (=11 doses), every other week x5\\] and twice-daily radiation \\[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\\]). Total duration is 10 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}, {'id': 'OG001', 'title': 'B: Cetuximab + PX', 'description': 'Cetuximab \\[250 mg/m2 (day 1, weekly x7)\\] + PX (Cisplatin \\[100mg/m2 (week 1 \\& 4 on day 1 (or 2))\\], Accelerated fraction radiotherapy with concomitant boost \\[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\\]). Total duration: 7 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Progressive Disease (PD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-Induction (8 weeks)', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate to CRT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Cetuximab+FHX', 'description': 'Cetuximab \\[250mg/m2 (day 1, weekly x10)\\] + FHX (5-FU \\[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\\], Hydroxyurea \\[500 mg PO BID, days 0-5 (=11 doses), every other week x5\\] and twice-daily radiation \\[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\\]). Total duration is 10 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}, {'id': 'OG001', 'title': 'B: Cetuximab + PX', 'description': 'Cetuximab \\[250 mg/m2 (day 1, weekly x7)\\] + PX (Cisplatin \\[100mg/m2 (week 1 \\& 4 on day 1 (or 2))\\], Accelerated fraction radiotherapy with concomitant boost \\[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\\]). Total duration: 7 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks', 'description': 'Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Residual Lymph Node Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: Cetuximab+FHX', 'description': 'Cetuximab \\[250mg/m2 (day 1, weekly x10)\\] + FHX (5-FU \\[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\\], Hydroxyurea \\[500 mg PO BID, days 0-5 (=11 doses), every other week x5\\] and twice-daily radiation \\[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\\]). Total duration is 10 weeks.\n\nCetuximab: 250mg/m2(day 1, weekly x 10);\n\n5-FU: 600 mg/m2/day; days 0-5 (120 h total) every other week x 5\n\nHydroxyurea: 500 mg PO BID, days 0-5 every other week x 5\n\nTwice-daily radiation: 150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)'}, {'id': 'OG001', 'title': 'B: Cetuximab + PX', 'description': 'Cetuximab \\[250 mg/m2 (day 1, weekly x7)\\] + PX (Cisplatin \\[100mg/m2 (week 1 \\& 4 on day 1 (or 2))\\], Accelerated fraction radiotherapy with concomitant boost \\[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\\]). Total duration: 7 weeks.\n\nCetuximab: 250mg/m2(day 1, weekly x 10);\n\nCisplatin: 100 mg/m2, week 1 and 4 on day 1 (or 2)\n\nAccelerated fraction radiotherapy with concomitant boost: 72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 weeks', 'description': 'Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (\\>1.5 cm) or focally abnormal lymph node.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A: Cetuximab+FHX', 'description': 'Cetuximab \\[250mg/m2 (day 1, weekly x10)\\] + FHX (5-FU \\[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\\], Hydroxyurea \\[500 mg PO BID, days 0-5 (=11 doses), every other week x5\\] and twice-daily radiation \\[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\\]). Total duration is 10 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}, {'id': 'FG001', 'title': 'B: Cetuximab + PX', 'description': 'Cetuximab \\[250 mg/m2 (day 1, weekly x7)\\] + PX (Cisplatin \\[100mg/m2 (week 1 \\& 4 on day 1 (or 2))\\], Accelerated fraction radiotherapy with concomitant boost \\[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\\]). Total duration: 7 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'A: Cetuximab+FHX', 'description': 'Cetuximab \\[250mg/m2 (day 1, weekly x10)\\] + FHX (5-FU \\[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\\], Hydroxyurea \\[500 mg PO BID, days 0-5 (=11 doses), every other week x5\\] and twice-daily radiation \\[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\\]). Total duration is 10 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}, {'id': 'BG001', 'title': 'B: Cetuximab + PX', 'description': 'Cetuximab \\[250 mg/m2 (day 1, weekly x7)\\] + PX (Cisplatin \\[100mg/m2 (week 1 \\& 4 on day 1 (or 2))\\], Accelerated fraction radiotherapy with concomitant boost \\[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\\]). Total duration: 7 weeks.\n\nCetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '81'}, {'value': '55.6', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '79'}, {'value': '55.8', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '93', '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': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2007-04-30', 'resultsFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2007-05-01', 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-20', 'studyFirstPostDateStruct': {'date': '2007-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': '1 years', 'description': 'Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': '2 years', 'description': 'Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '2 years', 'description': 'Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.'}, {'measure': 'Objective Response Rate to Induction', 'timeFrame': 'Post-Induction (8 weeks)', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}, {'measure': 'Objective Response Rate to CRT', 'timeFrame': 'From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks', 'description': 'Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.'}, {'measure': 'Residual Lymph Node Disease', 'timeFrame': 'Up to 10 weeks', 'description': 'Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (\\>1.5 cm) or focally abnormal lymph node.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cetuximab', 'Erbitux', 'locally', 'advanced', 'head', 'neck', 'cancer', 'neoplasms', 'squamous', 'carcinoma', 'lymphoepithelioma'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Stage III and IV head and neck cancer\n* Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area\n* No prior chemotherapy or radiotherapy\n* Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2\n* Normal organ and marrow function\n\nExclusion Criteria:\n\n* Unequivocal demonstration of metastatic disease\n* Known severe hypersensitivity to drugs used in the study\n* Treatment with a non-approved or investigational drug within 30 days before Day 1\n* Incomplete healing from previous surgery\n* Pregnancy or breast feeding\n* Uncontrolled intercurrent illness including\n* Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF\n* Acute hepatitis or known HIV\n* Severe baseline neurologic deficits\n* Prior therapy which specifically and directly targets the EGFR pathway\n* Prior severe infusion reaction to a monoclonal antibody'}, 'identificationModule': {'nctId': 'NCT00468169', 'acronym': 'EPIC', 'briefTitle': 'Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer', 'orgStudyIdInfo': {'id': '14401A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: Cetuximab+FHX', 'description': 'Cetuximab \\[250mg/m2 (day 1, weekly x10)\\] + FHX (5-FU \\[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\\], Hydroxyurea \\[500 mg PO BID, days 0-5 (=11 doses), every other week x5\\] and twice-daily radiation \\[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\\]). Total duration is 10 weeks.', 'interventionNames': ['Drug: Cetuximab', 'Drug: 5-FU', 'Drug: Hydroxyurea', 'Radiation: Twice-daily radiation']}, {'type': 'EXPERIMENTAL', 'label': 'B: Cetuximab + PX', 'description': 'Cetuximab \\[250 mg/m2 (day 1, weekly x7)\\] + PX (Cisplatin \\[100mg/m2 (week 1 \\& 4 on day 1 (or 2))\\], Accelerated fraction radiotherapy with concomitant boost \\[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\\]). Total duration: 7 weeks.', 'interventionNames': ['Drug: Cetuximab', 'Drug: Cisplatin', 'Radiation: Accelerated fraction radiotherapy with concomitant boost']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux (R)'], 'description': '250mg/m2(day 1, weekly x 10);', 'armGroupLabels': ['A: Cetuximab+FHX', 'B: Cetuximab + PX']}, {'name': '5-FU', 'type': 'DRUG', 'description': '600 mg/m2/day; days 0-5 (120 h total) every other week x 5', 'armGroupLabels': ['A: Cetuximab+FHX']}, {'name': 'Hydroxyurea', 'type': 'DRUG', 'description': '500 mg PO BID, days 0-5 every other week x 5', 'armGroupLabels': ['A: Cetuximab+FHX']}, {'name': 'Twice-daily radiation', 'type': 'RADIATION', 'description': '150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)', 'armGroupLabels': ['A: Cetuximab+FHX']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '100 mg/m2, week 1 and 4 on day 1 (or 2)', 'armGroupLabels': ['B: Cetuximab + PX']}, {'name': 'Accelerated fraction radiotherapy with concomitant boost', 'type': 'RADIATION', 'description': '72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.', 'armGroupLabels': ['B: Cetuximab + PX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Everett E Vokes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}