Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT00608205
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2008-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV 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': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adelstd@ccf.org', 'phone': '216-444-9310', 'title': 'Dr. David Adelstein', 'organization': 'Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over a 2 year period from study start.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Radiation With Concurrent Cisplatin', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.', 'otherNumAtRisk': 35, 'otherNumAffected': 35, 'seriousNumAtRisk': 35, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Arm B: Radiation With Concurrent 5-FU and Cisplatin', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.', 'otherNumAtRisk': 34, 'otherNumAffected': 34, 'seriousNumAtRisk': 34, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Cranial Neuropathy/ Hearing and Balance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dysphagia (difficulty swallowing)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 16}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Increased Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Skin Toxicity from Radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 30}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cranial Neuropathy/ Hearing and Balance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain-not otherwise specified (NOS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relapse Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 2 yrs from start of study', 'description': 'Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Patterns of Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'title': 'Local recurrence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Regional (nodal) recurrence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Distant recurrence', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years from start of study', 'description': 'Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 yrs from start of study', 'description': 'Number of patients still alive from 2 years from start of study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 weeks after completing chemoradiotherapy', 'description': 'Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Pathological(Final)Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 weeks after completing chemoradiotherapy and surgery', 'description': 'A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years after start of study', 'description': 'Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that had a complete response after 12 weeks of therapy'}, {'type': 'SECONDARY', 'title': 'Number of Patients That Required a Feeding Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (after treatment)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients That Required a Feeding Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 months after start of treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients That Required a Feeding Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after start of treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients That Required a Feeding Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months after start of treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Nausea Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I have nausea".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).\n\nN (number of patients analyzed) is based on number of patients who completed the question.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Nausea Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have nausea".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Nausea Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have nausea".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Nausea Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation With Concurrent Cisplatin', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Radiation With Concurrent 5-FU and Cisplatin', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have nausea".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Dry Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.33', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "My mouth is dry".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Dry Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.67', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 months from start of treatment', 'description': 'Quality of life questionnaire asking "My mouth is dry".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Dry Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months from start of treatment', 'description': 'Quality of life questionnaire asking "My mouth is dry".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Dry Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.60', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '2.94', 'spread': '1.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months from start of treatment', 'description': 'Quality of life questionnaire asking "My mouth is dry".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I have pain in my mouth, throat or neck".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have pain in my mouth, throat or neck".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.57', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have pain in my mouth, throat or neck".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.60', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have pain in my mouth, throat or neck".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.37', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I am content with the quality of my life right now".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am content with the quality of my life right now".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am content with the quality of my life right now".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am content with the quality of my life right now".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '2.28', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I am able to eat the foods i like".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.93', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am able to eat the foods i like".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.56', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am able to eat the foods i like".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.52', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am able to eat the foods i like".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Swallowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.93', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I can swallow naturally and easily".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Swallowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.31', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can swallow naturally and easily".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Swallowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.61', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can swallow naturally and easily".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Swallowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.63', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can swallow naturally and easily".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Alcohol Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.28', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Alcohol Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.96', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 months after start of treatment', 'description': 'Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Alcohol Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.85', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after start of treatment', 'description': 'Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Alcohol Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.85', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months after start of treatment', 'description': 'Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Solid Foods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.41', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I can eat solid foods".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Solid Foods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can eat solid foods".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Solid Foods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can eat solid foods".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Solid Foods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can eat solid foods".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Radiation With Concurrent Cisplatin', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'FG001', 'title': 'Arm B: Radiation With Concurrent 5-FU and Cisplatin', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Patient non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients recruited from Cleveland, Ohio medical clinics from December 2007 to August 2012.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Radiation With Concurrent Cisplatin', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.'}, {'id': 'BG001', 'title': 'Arm B: Radiation With Concurrent 5-FU and Cisplatin', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '40-49 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', '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'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2008-01-30', 'resultsFirstSubmitDate': '2013-07-11', 'studyFirstSubmitQcDate': '2008-01-31', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-11', 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse Free Survival', 'timeFrame': 'at 2 yrs from start of study', 'description': 'Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..'}], 'secondaryOutcomes': [{'measure': 'Patterns of Failure', 'timeFrame': '2 years from start of study', 'description': 'Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.'}, {'measure': 'Overall Survival', 'timeFrame': '2 yrs from start of study', 'description': 'Number of patients still alive from 2 years from start of study'}, {'measure': 'Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor', 'timeFrame': 'at 12 weeks after completing chemoradiotherapy', 'description': 'Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.'}, {'measure': 'Number of Patients With a Pathological(Final)Complete Response', 'timeFrame': 'at 12 weeks after completing chemoradiotherapy and surgery', 'description': 'A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.'}, {'measure': 'Disease Recurrence', 'timeFrame': '2 years after start of study', 'description': 'Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.'}, {'measure': 'Number of Patients That Required a Feeding Tube', 'timeFrame': '12 weeks (after treatment)'}, {'measure': 'Number of Patients That Required a Feeding Tube', 'timeFrame': '8 months after start of treatment'}, {'measure': 'Number of Patients That Required a Feeding Tube', 'timeFrame': '12 months after start of treatment'}, {'measure': 'Number of Patients That Required a Feeding Tube', 'timeFrame': '24 months after start of treatment'}, {'measure': 'Nausea Level', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I have nausea".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).\n\nN (number of patients analyzed) is based on number of patients who completed the question.'}, {'measure': 'Nausea Level', 'timeFrame': '8 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have nausea".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Nausea Level', 'timeFrame': '12 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have nausea".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Nausea Level', 'timeFrame': '24 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have nausea".'}, {'measure': 'Dry Mouth', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "My mouth is dry".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Dry Mouth', 'timeFrame': '8 months from start of treatment', 'description': 'Quality of life questionnaire asking "My mouth is dry".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Dry Mouth', 'timeFrame': '12 months from start of treatment', 'description': 'Quality of life questionnaire asking "My mouth is dry".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Dry Mouth', 'timeFrame': '24 months from start of treatment', 'description': 'Quality of life questionnaire asking "My mouth is dry".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Pain', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I have pain in my mouth, throat or neck".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Pain', 'timeFrame': '8 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have pain in my mouth, throat or neck".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Pain', 'timeFrame': '12 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have pain in my mouth, throat or neck".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Pain', 'timeFrame': '24 months from start of treatment', 'description': 'Quality of life questionnaire asking "I have pain in my mouth, throat or neck".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Quality of Life', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I am content with the quality of my life right now".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Quality of Life', 'timeFrame': '8 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am content with the quality of my life right now".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Quality of Life', 'timeFrame': '12 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am content with the quality of my life right now".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Quality of Life', 'timeFrame': '24 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am content with the quality of my life right now".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Eating', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I am able to eat the foods i like".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Eating', 'timeFrame': '8 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am able to eat the foods i like".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Eating', 'timeFrame': '12 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am able to eat the foods i like".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Eating', 'timeFrame': '24 months from start of treatment', 'description': 'Quality of life questionnaire asking "I am able to eat the foods i like".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Swallowing', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I can swallow naturally and easily".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Swallowing', 'timeFrame': '8 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can swallow naturally and easily".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Swallowing', 'timeFrame': '12 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can swallow naturally and easily".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Swallowing', 'timeFrame': '24 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can swallow naturally and easily".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Alcohol Consumption', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Alcohol Consumption', 'timeFrame': '8 months after start of treatment', 'description': 'Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Alcohol Consumption', 'timeFrame': '12 months after start of treatment', 'description': 'Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Alcohol Consumption', 'timeFrame': '24 months after start of treatment', 'description': 'Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Solid Foods', 'timeFrame': '12 weeks (after treatment)', 'description': 'Quality of life questionnaire asking "I can eat solid foods".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Solid Foods', 'timeFrame': '8 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can eat solid foods".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Solid Foods', 'timeFrame': '12 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can eat solid foods".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}, {'measure': 'Solid Foods', 'timeFrame': '24 months after start of treatment', 'description': 'Quality of life questionnaire asking "I can eat solid foods".\n\nThe Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage III squamous cell carcinoma of the hypopharynx', 'stage III squamous cell carcinoma of the lip and oral cavity', 'stage III squamous cell carcinoma of the oropharynx', 'stage III squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'stage IV squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the larynx'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer.\n\nPURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To compare the relapse-free survival of patients treated with radiotherapy and cisplatin with vs without fluorouracil.\n* To compare the overall survival, local control without surgery, and patterns of failure in patients treated with these regimens.\n* To compare the acute and long-term toxicity of these regimens in these patients.\n* To compare the quality of life of patients treated with these regimens.\n* To prospectively collect biopsy material, mucosal scrapings, and serum in an effort to generate hypotheses for future correlative studies.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to radiotherapy schedule (once daily vs twice daily) and radiotherapy planning (2D vs 3D vs intensity-modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.\n* Arm II: Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.\n\nPatients with biopsy-verified residual disease at the primary site or local recurrence after achieving a complete response to chemoradiotherapy may undergo salvage surgery 12 weeks after the completion of chemoradiotherapy.\n\nPatients complete questionnaires periodically to assess late toxicity and quality of life.\n\nAfter completion of study treatment, patients are followed periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx\n\n * No histologic diagnosis other than squamous cell carcinoma\n * A primary site must be identified\n* Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease\n\n * No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0)\n * No stage IVC disease (stage IVB disease allowed)\n* Deemed appropriate for definitive non-operative management with curative intent\n\n * Resectable disease is not required\n* No primary cancer of the nasopharynx, paranasal sinus, or salivary gland\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* WBC \\> 3,500/mm³\n* Platelet count \\> 100,000/mm³\n* Serum creatinine \\< 2.0 mg/dL\n* Alkaline phosphatase \\< 2 times normal\n* AST \\< 2 times normal\n* Bilirubin ≤ 2.0 mg/dL\n* Serum calcium normal\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No unstable or uncontrolled angina\n* No clinically apparent jaundice\n* No active infection\n* No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ), unless the patient has been continuously disease-free for at least 5 years\n* Not a poor compliance risk\n* Able to withstand the rigors of intensive treatment\n* Available for and compliant with adequate long-term follow-up\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior definitive surgery or radiotherapy for this malignancy\n* No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for any disease Patients who have had previous definitive surgery, or radiation therapy for this malignancy, and patients who have had any previous chemotherapy, immunotherapy, or EGF receptor inhibition for any disease are ineligible.\n\nExclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible.\n\nPatients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible.\n\nPatients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years.\n\nPatients with any histologic diagnosis other than squamous cell carcinoma are ineligible.\n\nPatients who might be a poor-compliance risk are ineligible.\n\nPregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy.'}, 'identificationModule': {'nctId': 'NCT00608205', 'briefTitle': 'Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'CASE3307'}, 'secondaryIdInfos': [{'id': 'NCI-2010-01197', 'type': 'OTHER', 'domain': 'NCI/CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A: Radiation with concurrent Cisplatin', 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.', 'interventionNames': ['Drug: cisplatin', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Radiation with concurrent 5-FU and Cisplatin', 'description': 'Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.', 'interventionNames': ['Drug: cisplatin', 'Drug: fluorouracil', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'otherNames': ['CDDP'], 'description': 'Given IV', 'armGroupLabels': ['Arm A: Radiation with concurrent Cisplatin', 'Arm B: Radiation with concurrent 5-FU and Cisplatin']}, {'name': 'fluorouracil', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Arm B: Radiation with concurrent 5-FU and Cisplatin']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'otherNames': ['radiation'], 'description': 'Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks', 'armGroupLabels': ['Arm A: Radiation with concurrent Cisplatin', 'Arm B: Radiation with concurrent 5-FU and Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'David J. Adelstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center'}, {'name': 'Panayiotis Savvides, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}