Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT01359956
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2011-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'C054368', 'term': 'fotemustine'}, {'id': 'D000077190', 'term': 'Interferon alpha-2'}], 'ancestors': [{'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'p.ascierto@istitutotumori.na.it', 'phone': '+39 081 5903431', 'title': 'Paolo A Ascierto, M.D., Ph.D', 'organization': 'NCI Naples'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'A1 - Combination Chemotherapy Without Interferon', 'description': 'combination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle', 'otherNumAtRisk': 62, 'otherNumAffected': 12, 'seriousNumAtRisk': 62, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'A2 - Combination Chemotherapy With Interferon', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week', 'otherNumAtRisk': 67, 'otherNumAffected': 25, 'seriousNumAtRisk': 67, 'seriousNumAffected': 27}, {'id': 'EG002', 'title': 'B1 - Single Agent Dacarbazine Without Interferon', 'description': 'single agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle', 'otherNumAtRisk': 71, 'otherNumAffected': 16, 'seriousNumAtRisk': 71, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'B2 - Single Agent Dacarbazine Plus Interferon', 'description': 'single agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week', 'otherNumAtRisk': 52, 'otherNumAffected': 13, 'seriousNumAtRisk': 52, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 62, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 67, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 72, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 52, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 62, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 67, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 72, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 52, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 67, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 72, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 52, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fotemustine/Dacarbazine/Interferon + Fotemustine/Dacarbazine', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\ncombination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle'}, {'id': 'OG001', 'title': 'Dacarbazine/Interferon + Dacarbazine', 'description': 'single agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\nsingle agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle'}, {'id': 'OG002', 'title': 'Fotemustine/Dacarbazine/Interferon+Dacarbazine/Interferon', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\nsingle agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week'}, {'id': 'OG003', 'title': 'Fotemustine/Dacarbazine + Dacarbazine', 'description': 'combination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nsingle agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '10.2'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '10.4'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '6.3', 'upperLimit': '11.1'}, {'value': '7.7', 'groupId': 'OG003', 'lowerLimit': '6.3', 'upperLimit': '9.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 months', 'description': 'Overall Survival was defined as the time from the date of randomisation to the date of death from any cause or the date of last follow-up for living patients.\n\nOS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two - sided log - rank test.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine patients were lost to follow-up immediately after randomization and, in particular, for FDI + FD 132, instead of 136 randomized (4 lost pts.), for DI + D, 128 instead of 133 (5 lost pts.), for FD1 + DI 126, instead of 131 (5 lost pts.), 134 instead of 138 (4 lost pts.)'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fotemustine/Dacarbazine/Interferon + Fotemustine/Dacarbazine', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\ncombination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle'}, {'id': 'OG001', 'title': 'Dacarbazine/Interferon + Dacarbazine', 'description': 'single agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\nsingle agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle'}, {'id': 'OG002', 'title': 'Fotemustine/Dacarbazine/Interferon+Dacarbazine/Interferon', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\nsingle agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week'}, {'id': 'OG003', 'title': 'Fotemustine/Dacarbazine + Dacarbazine', 'description': 'combination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nsingle agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '3.8'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '3.7'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '3.9'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '2.3', 'upperLimit': '2.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'Progression Free Survival (PFS) was defined as the time from the date of randomisation to the date of progression of disease or death from any cause, whichever occurred first, or date of last follow-up for patients without progression and alive at the end of the study.\n\nPFS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two-sided log-rank test.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine patients were lost to follow-up immediately after randomization and, in particular, for FDI + FD 132, instead of 136 randomized (4 lost pts.), for DI + D, 128 instead of 133 (5 lost pts.), for FD1 + DI 126, instead of 131 (5 lost pts.), 134 instead of 138 (4 lost pts.).'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fotemustine/Dacarbazine/Interferon + Fotemustine/Dacarbazine', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\ncombination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle'}, {'id': 'OG001', 'title': 'Dacarbazine/Interferon + Dacarbazine', 'description': 'single agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\nsingle agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle'}, {'id': 'OG002', 'title': 'Fotemustine/Dacarbazine/Interferon+Dacarbazine/Interferon', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\nsingle agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week'}, {'id': 'OG003', 'title': 'Fotemustine/Dacarbazine + Dacarbazine', 'description': 'combination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nsingle agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 weeks from start of therapy', 'description': 'Overall Response Rate (ORR) included Complete Response (CR) and Partial Response (PR).\n\nComplete Response (CR) was defined as disappearance of all symptoms and signs of all measurable disease, lasting for at least four weeks, without appearance of new lesions.\n\nPartial Response (PR) was defined as a \\> 50% reduction in the sum of the products of the perpendicular diameters of all measurable lesions, lasting for at least four weeks, without appearance of new lesions or enlargement of existing lesions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine patients were lost to follow-up immediately after randomization and, in particular, for FDI + FD 132, instead of 136 randomized (4 lost pts.), for DI + D 128, instead of 133 (5 lost pts.), for FD1 + DI 126, instead of 131 (5 lost pts.), 134, instead of 138 (4 lost pts.).'}, {'type': 'SECONDARY', 'title': 'Treatment Related Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fotemustine/Dacarbazine/Interferon + Fotemustine/Dacarbazine', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\ncombination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle'}, {'id': 'OG001', 'title': 'Dacarbazine/Interferon + Dacarbazine', 'description': 'single agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\nsingle agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle'}, {'id': 'OG002', 'title': 'Fotemustine/Dacarbazine/Interferon+Dacarbazine/Interferon', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week\n\nsingle agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week'}, {'id': 'OG003', 'title': 'Fotemustine/Dacarbazine + Dacarbazine', 'description': 'combination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nsingle agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at end of each 3 week cycle of therapy up to the discontinuation', 'description': 'worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "It wasn't possible to assess the treatment related toxicity for all the patients included in the study because for some of them, no data were collected.\n\nIt's difficult to indicate the exact number of participants affected by the worst grade CTC toxicity because the same patient could be affected by one or more side effects."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A1 - Combination Chemotherapy Without Interferon', 'description': 'combination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle'}, {'id': 'FG001', 'title': 'A2 - Combination Chemotherapy With Interferon', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week'}, {'id': 'FG002', 'title': 'B1 - Single Agent Dacarbazine Without Interferon', 'description': 'single agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle'}, {'id': 'FG003', 'title': 'B2 - Single Agent Dacarbazine Plus Interferon', 'description': 'single agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '57'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were randomly assigned to one of four treatment groups. Patients were randomized through a computerized procedure of permuted blocks centralized at the coordinating center (Medical Oncology, NCI Napoli), stratified by PS (0-1,2) and site of metastases (visceral, not visceral).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '260', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'A1 - Combination Chemotherapy Without Interferon', 'description': 'combination chemotherapy without interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle'}, {'id': 'BG001', 'title': 'A2 - Combination Chemotherapy With Interferon', 'description': 'combination chemotherapy with interferon\n\nFotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle\n\nDacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle\n\nInterferon Alfa-2b: α2b 5 MUI three times per week'}, {'id': 'BG002', 'title': 'B1 - Single Agent Dacarbazine Without Interferon', 'description': 'single agent dacarbazine without interferon\n\nDacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle'}, {'id': 'BG003', 'title': 'B2 - Single Agent Dacarbazine Plus Interferon', 'description': 'single agent dacarbazine plus interferon\n\nDacarbazine: 900 mg / m2 every 3 weeks\n\nInterferon Alfa-2b: α2b 5 MUI three times per week'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '13', 'groupId': 'BG000'}, {'value': '50', 'spread': '15', 'groupId': 'BG001'}, {'value': '59', 'spread': '15', 'groupId': 'BG002'}, {'value': '56', 'spread': '14', 'groupId': 'BG003'}, {'value': '55', 'spread': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '103', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '157', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '260', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Nodular melanoma', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2011-05-13', 'resultsFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-18', 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '24 months', 'description': 'Overall Survival was defined as the time from the date of randomisation to the date of death from any cause or the date of last follow-up for living patients.\n\nOS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two - sided log - rank test.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': '12 months', 'description': 'Progression Free Survival (PFS) was defined as the time from the date of randomisation to the date of progression of disease or death from any cause, whichever occurred first, or date of last follow-up for patients without progression and alive at the end of the study.\n\nPFS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two-sided log-rank test.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': '18 weeks from start of therapy', 'description': 'Overall Response Rate (ORR) included Complete Response (CR) and Partial Response (PR).\n\nComplete Response (CR) was defined as disappearance of all symptoms and signs of all measurable disease, lasting for at least four weeks, without appearance of new lesions.\n\nPartial Response (PR) was defined as a \\> 50% reduction in the sum of the products of the perpendicular diameters of all measurable lesions, lasting for at least four weeks, without appearance of new lesions or enlargement of existing lesions.'}, {'measure': 'Treatment Related Toxicity', 'timeFrame': 'at end of each 3 week cycle of therapy up to the discontinuation', 'description': 'worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Melanoma', 'Recurrent Melanoma']}, 'referencesModule': {'references': [{'pmid': '23402397', 'type': 'RESULT', 'citation': 'Daponte A, Signoriello S, Maiorino L, Massidda B, Simeone E, Grimaldi AM, Caraco C, Palmieri G, Cossu A, Botti G, Petrillo A, Lastoria S, Cavalcanti E, Aprea P, Mozzillo N, Gallo C, Comella G, Ascierto PA; Southern Italy Cooperative Oncology Group (SICOG). Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-alpha in advanced malignant melanoma. J Transl Med. 2013 Feb 13;11:38. doi: 10.1186/1479-5876-11-38.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of malignant melanoma in advanced stage or recurrent after surgery, and not amenable to further surgery or local therapy.\n* Presence of measurable disease\n* Age \\> or = 18 years and \\< or = 75 years\n* Performance status (ECOG) 0 - 2 (Appendix 2)\n* Life expectancy ³ 3 months\n* Adequate bone marrow function (ANC ³ 2,000/mmc; PTL ³ 100,000/mmc; Hb ³ 10 gr/dl), normal liver and renal function (bilirubin \\< 1.25 x N, creatinine \\< 1.25 x N, SGOT, SGPT \\< 3 times upper normal limit of testing laboratory.\n* Written, informed consent prior to study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.\n* Prior surgery \\> 3 weeks from initiating .\n* If palliative radiation is needed, in case of non target lesions, it must be given prior to initiating chemotherapy. If palliative radiation is required during the study the patient should be permanently discontinued from further treatment.\n* Adequate contraceptive measures during study participation for sexually active patients of child bearing potential must implement.\n\nExclusion Criteria:\n\n* Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.\n* Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed)\n* Known HIV disease.\n* Concurrent treatment with other experimental drugs.\n* Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy\n* Pregnant or lactating females Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.\n\nPrior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed) Known HIV disease. Concurrent treatment with other experimental drugs. Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy'}, 'identificationModule': {'nctId': 'NCT01359956', 'acronym': 'SICOG 0109', 'briefTitle': 'Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Naples'}, 'officialTitle': 'Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study', 'orgStudyIdInfo': {'id': 'SICOG 0109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1', 'description': 'combination chemotherapy without interferon', 'interventionNames': ['Drug: Dacarbazine', 'Drug: Fotemustine']}, {'type': 'EXPERIMENTAL', 'label': 'A2', 'description': 'combination chemotherapy with interferon', 'interventionNames': ['Drug: Dacarbazine', 'Drug: Fotemustine', 'Drug: Interferon Alfa-2b']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B1', 'description': 'single agent dacarbazine without interferon', 'interventionNames': ['Drug: Dacarbazine']}, {'type': 'EXPERIMENTAL', 'label': 'B2', 'description': 'single agent dacarbazine plus interferon', 'interventionNames': ['Drug: Dacarbazine', 'Drug: Interferon Alfa-2b']}], 'interventions': [{'name': 'Dacarbazine', 'type': 'DRUG', 'description': '900 mg / m2 every 3 weeks', 'armGroupLabels': ['A1', 'A2', 'B1', 'B2']}, {'name': 'Fotemustine', 'type': 'DRUG', 'description': '100 mg / m2 every 3 weeks', 'armGroupLabels': ['A1', 'A2']}, {'name': 'Interferon Alfa-2b', 'type': 'DRUG', 'description': '5 M units every 3 weeks', 'armGroupLabels': ['A2', 'B2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paolo A Ascierto, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NCI Naples'}, {'name': 'Antonio Daponte, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NCI Naples'}, {'name': 'Simona Signoriello, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campania Luigi Vanvitelli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Naples', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}