Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-29 @ 11:56 PM
Study NCT ID:
NCT02347332
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2014-11-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111217', 'term': 'vinflunine'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zahida.issiakhem@pierre-fabre.com', 'phone': '+33 5 34 50 61 71', 'title': 'Zahida Issiakhem, Clinical Development Physician', 'organization': 'Institut de Recherche Pierre Fabre, Toulouse France'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Sponsor ended recrutement and decided to limit analysis of efficacy.'}}, 'adverseEventsModule': {'timeFrame': '4 years 6 months 29 days. 5 subjects in the Vinflunine + Methotrexate arm and 2 patients in the Methotrexate arm did not receive any treatment. These patients were thus excluded from the safety population.The safety population consisted of all patients randomized and treated.', 'eventGroups': [{'id': 'EG000', 'title': 'Vinflunine Plus Methotrexate', 'description': 'Vinflunine IV 280mg/m2 Day1 plus Methotrexate IV 30mg/m2 on Day 1 and Dy 8 every 3 cycles\n\nVinflunine', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 211, 'seriousNumAtRisk': 225, 'deathsNumAffected': 185, 'seriousNumAffected': 106}, {'id': 'EG001', 'title': 'Methotrexate', 'description': 'Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks\n\nMethotrexate', 'otherNumAtRisk': 227, 'deathsNumAtRisk': 227, 'otherNumAffected': 213, 'seriousNumAtRisk': 227, 'deathsNumAffected': 194, 'seriousNumAffected': 81}], 'otherEvents': [{'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 248, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 150, 'numAffected': 63}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 49, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 28, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 47, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 227, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 26, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 74, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 58, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 29, 'numAffected': 12}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 34, 'numAffected': 18}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 32, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 52, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 219, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 190, 'numAffected': 71}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 245, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 147, 'numAffected': 56}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 93, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 102, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 31, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 65, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 42, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 27, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 181, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 137, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 53, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 52, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 53, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 48, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 55, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 163, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 42, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 117, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 158, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 66, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 40, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 37, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 20, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 34, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 23, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 33, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 45, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 40, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 30, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 59, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 45, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 16}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Tumour Haemorrage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 10}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Tumour Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'General Physical Health Deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival in the ITT Population (Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinflunine Plus Methotrexate', 'description': 'Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks\n\nVinflunine'}, {'id': 'OG001', 'title': 'Methotrexate', 'description': 'Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks\n\nMethotrexate'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '8.4'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '8.0'}]}]}], 'analyses': [{'pValue': '0.8329', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'Threshold significance value p\\<0.05', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Participants will be followed till death (if they are not lost for follow-up), an expected average of 7.5 months', 'description': 'Time from randomization to the date of death or last follow-up. The survival duration of patients still alive, was censored at the date of last contact or last follow-up.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinflunine Plus Methotrexate', 'description': 'Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks\n\nVinflunine'}, {'id': 'OG001', 'title': 'Methotrexate', 'description': 'Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks\n\nMethotrexate'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '3.3'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.1'}]}]}], 'analyses': [{'pValue': '0.3576', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'Threshold significance value p\\<0.05', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'an expected average of 4 months', 'description': 'Time measured from the date of randomisation until date of progression or death from any cause (whichever came first)', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinflunine Plus Methotrexate', 'description': 'Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks\n\nVinflunine'}, {'id': 'OG001', 'title': 'Methotrexate', 'description': 'Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks\n\nMethotrexate'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '23.4'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '20.1'}]}]}], 'analyses': [{'pValue': '0.467', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'Threshold significance value p\\<0.05', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'The objective response is defined as the best response designation recorded across all time points from the date of randomisation until disease progression.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinflunine Plus Methotrexate', 'description': 'Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks\n\nVinflunine'}, {'id': 'OG001', 'title': 'Methotrexate', 'description': 'Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks\n\nMethotrexate'}], 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000', 'lowerLimit': '44.2', 'upperLimit': '57.5'}, {'value': '46.3', 'groupId': 'OG001', 'lowerLimit': '39.7', 'upperLimit': '53.0'}]}]}], 'analyses': [{'pValue': '0.243', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'Threshold significance value p\\<0.05', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '30 months', 'description': 'Percentage of best overall responses CR, PR and SD in the analysed population', 'unitOfMeasure': '% patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinflunine Plus Methotrexate', 'description': 'Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks\n\nVinflunine'}, {'id': 'OG001', 'title': 'Methotrexate', 'description': 'Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks\n\nMethotrexate'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '5.6'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '5.1'}]}]}], 'analyses': [{'pValue': '0.6289', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'Threshold significance value p\\<0.05', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '30 months', 'description': 'Duration of objective response will be measured for responders (CR+PR) from the time for CR or PR until the 1st date of documentation of recurrent or progressive disease or the date of death any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vinflunine Plus Methotrexate', 'description': 'Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks\n\nVinflunine'}, {'id': 'FG001', 'title': 'Methotrexate', 'description': 'Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks\n\nMethotrexate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '229'}]}, {'type': 'COMPLETED', 'comment': 'Were considered as discontinued the 12 patients dead due to various or unknown reasons.', 'achievements': [{'comment': '6 patients: suicide(1), unknown cause(5 - 4 at home +1 in city hospital).', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '6 patients: unknown cause(2home), PDsuspect(1home+1hosp), sudden death(1home), hypercapnie(1hosp).', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '229'}]}], 'dropWithdraws': [{'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Death (Unknown, Various reasons)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Protocol requirement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Switch Post-Trial program', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '5 patients in VFL+MET arrm and 2 patients in MET arm did not receive any treatement. These patients excluded from safety population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vinflunine Plus Methotrexate', 'description': 'Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks\n\nVinflunine'}, {'id': 'BG001', 'title': 'Methotrexate', 'description': 'Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks\n\nMethotrexate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Belarus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Estonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-05', 'size': 4045297, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-06T03:06', 'hasProtocol': True}, {'date': '2017-11-23', 'size': 2310210, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-06T05:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 459}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2014-11-18', 'resultsFirstSubmitDate': '2018-06-26', 'studyFirstSubmitQcDate': '2015-01-21', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-01', 'studyFirstPostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival in the ITT Population (Months)', 'timeFrame': 'Participants will be followed till death (if they are not lost for follow-up), an expected average of 7.5 months', 'description': 'Time from randomization to the date of death or last follow-up. The survival duration of patients still alive, was censored at the date of last contact or last follow-up.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'an expected average of 4 months', 'description': 'Time measured from the date of randomisation until date of progression or death from any cause (whichever came first)'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': '6 weeks', 'description': 'The objective response is defined as the best response designation recorded across all time points from the date of randomisation until disease progression.'}, {'measure': 'Disease Control Rate', 'timeFrame': '30 months', 'description': 'Percentage of best overall responses CR, PR and SD in the analysed population'}, {'measure': 'Duration of Response', 'timeFrame': '30 months', 'description': 'Duration of objective response will be measured for responders (CR+PR) from the time for CR or PR until the 1st date of documentation of recurrent or progressive disease or the date of death any cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vinflunin', 'Vinflunin + Methotrexate', 'Metastatic Squamous Cell Carcinoma of the Head and Neck'], 'conditions': ['Recurrent or Metastatic Head and Neck Carcinoma']}, 'descriptionModule': {'briefSummary': 'For patients relapsing after platinum-based therapy, few data are available. The current use of cetuximab associated with radiotherapy in localized disease and associated with platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine demonstrated superior antitumour activity to vinorelbine in preclinical animal models. Recent preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN, based on a clinical review, show encouraging antitumour activity and an acceptable safety profile. Therefore the combination of vinflunine and methotrexate appears a promising salvage regimen after platinum failure.\n\nThe present study has been designed as a multicenter, randomised phase III study which will compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN patients having failed platinum-based therapy.', 'detailedDescription': 'This study was designed to compare the OS of VFL plus MTX versus MTX alone in patients with SCCHN who had failed platinum-based chemotherapy.\n\nThe trial was designed in accordance with current standards used routinely in oncology phase III trials and used established methods of assessment. The RECIST (version 1.1) and NCI CTCAE (version 3.0) guidelines are internationally recognised methods for assessing efficacy and tolerance, respectively.\n\nThe patient population was appropriate for this type of phase III study and included adult patients with recurrent and/or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, who had received prior chemotherapy regimens with documented progression. This population of patients was considered appropriate to meet the study objectives.\n\nRecent preliminary phase I results of the VFL plus MTX combination in SCCHN, reported in a clinical review, showed encouraging antitumour activity and an acceptable safety profile A number of chemotherapy agents have been reported as having single-agent activity in SCCHN. However, reliable evidence of efficacy in the second-line setting is lacking, and there is currently no established standard of care. MTX used alone as the reference regimen at a dose of 40 mg/m2/week can be considered as the best available evidence-based option. Also, other trials using this comparator have demonstrated that it is generally accepted as a reasonable choice, and is often used in general practice.\n\nThe efficacy and safety assessments employed in this study are standard measures routinely used in studies of this type'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma\n* Documented progressive disease after chemotherapy for locoregionally advanced or recurrent/metastatic SCCHN which included a platinum derivative\n* Measurable or non measurable disease\n* adequate haematological, hepatic and renal functions\n* WHO performance status \\< 1\n\nExclusion Criteria:\n\n* Nasopharyngeal carcinoma\n* History of brain or leptomeningeal involvement\n* Albumin level \\< 35 g/L\n* Patients with weight loss ≥ 5% within the last 3 months\n* Grade \\> 2 peripheral neuropathy at study entry\n* "Third space" fluids (pleural effusion, ascites, massive edema)\n* Prior treatment with vinca-alkaloids and methotrexate'}, 'identificationModule': {'nctId': 'NCT02347332', 'briefTitle': 'Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'officialTitle': 'Phase III Study of IV Vinflunine in Combination With Methotrexate Versus Methotrexate Alone in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Chemotherapy', 'orgStudyIdInfo': {'id': 'L00070 IN 309 F0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vinflunine plus methotrexate', 'description': 'vinflunine IV 280 mg/m² Day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks', 'interventionNames': ['Drug: Vinflunine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methotrexate', 'description': 'methotrexate IV 40 mg/m² Day 1, 8 and 15 every 3 weeks', 'interventionNames': ['Drug: Methotrexate']}], 'interventions': [{'name': 'Vinflunine', 'type': 'DRUG', 'otherNames': ['JAVLOR', 'VFL'], 'armGroupLabels': ['Vinflunine plus methotrexate']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['MTX'], 'armGroupLabels': ['Methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'Institut de Recherche Pierre Fabre', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Zahida Issiakhem, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut de Recherche Pierre Fabre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}