Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-01-28 @ 7:10 PM
Study NCT ID:
NCT01164202
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2010-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karine.le-malicot@u-bourgogne.fr', 'phone': '+33 3 80 39 34 79', 'title': 'Mrs Karine Le Malicot', 'organization': 'FFCD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to the end of treatment, on the average of 36 months', 'eventGroups': [{'id': 'EG000', 'title': 'Sunitinib', 'description': 'sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year\n\nsunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: chemoembolization', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 27, 'seriousNumAtRisk': 39, 'deathsNumAffected': 32, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo 3cps/days 4 weeks over 6 during 1 year\n\nPlacebo: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: chemoembolization', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 36, 'seriousNumAtRisk': 38, 'deathsNumAffected': 30, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Liver pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'ALAT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'ASAT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 17}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Increase GGT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Bilirubine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Liver failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Phosphatases alcalines', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Hemoglobine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Leucocytose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Neutrophiles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Ascite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Lipase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Hand-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Prothrombin time', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Encephalopathia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}], 'seriousEvents': [{'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Ascite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Black stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Lumbar pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Neutrophiles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Hepatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Endocardite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 3cps/days 4 weeks over 6 during 1 year\n\nPlacebo: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: Chemoembolisation'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year\n\nsunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: Chemoembolisation'}], 'classes': [{'categories': [{'measurements': [{'value': '5.88', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '19.68'}, {'value': '2.78', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '14.53'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 days following each TACE, up to 5 months of treatment', 'description': 'The number of patients with at least one bleed and/or liver failure by treatment group', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat modified population'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 3cps/days 4 weeks over 6 during 1 year\n\nPlacebo: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: chemoembolization'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year\n\nsunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: chemoembolization'}], 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '30.6'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '13.5', 'upperLimit': '36.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until death or last news for alive patients, up to 3 years', 'description': 'Overall survival is defined as the time from the date of randomization to the date of death (from any cause).\n\nPatients lost to follow-up or alive at the time of analysis are censored at the last news date or the point date.\n\nThis time is used to calculate the median follow-up time.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 3cps/days 4 weeks over 6 during 1 year\n\nPlacebo: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: chemoembolization'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year\n\nsunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: chemoembolization'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '7.8'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '11.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first', 'description': 'Disease-free survival is defined as the time interval between randomization and local or distant relapse or second cancer or death (all causes). Alive patients are censored at the last follow-up.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'placebo 3cps/days 4 weeks over 6 during 1 year\n\nPlacebo: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: Chemoembolisation'}, {'id': 'FG001', 'title': 'Sunitinib', 'description': 'sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year\n\nsunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: Chemoembolisation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '78 patients were included by 17 centers'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'placebo 3cps/days 4 weeks over 6 during 1 year\n\nPlacebo: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: Chemoembolisation'}, {'id': 'BG001', 'title': 'Sunitinib', 'description': 'sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year\n\nsunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year\n\ntransarterial chemoembolization: Chemoembolisation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'BG000', 'lowerLimit': '43.69', 'upperLimit': '82.65'}, {'value': '65.97', 'groupId': 'BG001', 'lowerLimit': '46.03', 'upperLimit': '84.65'}, {'value': '66.44', 'groupId': 'BG002', 'lowerLimit': '43.69', 'upperLimit': '84.65'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', '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': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-01-23', 'size': 777673, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-17T03:54', 'hasProtocol': True}, {'date': '2015-02-01', 'size': 1212734, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-12T09:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-17', 'studyFirstSubmitDate': '2010-07-15', 'resultsFirstSubmitDate': '2021-08-23', 'studyFirstSubmitQcDate': '2010-07-15', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-17', 'studyFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure', 'timeFrame': 'Up to 7 days following each TACE, up to 5 months of treatment', 'description': 'The number of patients with at least one bleed and/or liver failure by treatment group'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From randomization until death or last news for alive patients, up to 3 years', 'description': 'Overall survival is defined as the time from the date of randomization to the date of death (from any cause).\n\nPatients lost to follow-up or alive at the time of analysis are censored at the last news date or the point date.\n\nThis time is used to calculate the median follow-up time.'}, {'measure': 'Disease-free Survival', 'timeFrame': 'From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first', 'description': 'Disease-free survival is defined as the time interval between randomization and local or distant relapse or second cancer or death (all causes). Alive patients are censored at the last follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adult primary hepatocellular carcinoma', 'localized unresectable adult primary liver cancer', 'advanced adult primary liver cancer'], 'conditions': ['Liver Cancer']}, 'referencesModule': {'references': [{'pmid': '32576496', 'type': 'RESULT', 'citation': 'Turpin A, de Baere T, Heurgue A, Le Malicot K, Ollivier-Hourmand I, Lecomte T, Perrier H, Vergniol J, Sefrioui D, Rinaldi Y, Edeline J, Jouve JL, Silvain C, Becouarn Y, Dauvois B, Baconnier M, Debette-Gratien M, Deplanque G, Dharancy S, Lepage C, Hebbar M; PRODIGE 16 investigators Collaborators. Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study. Clin Res Hepatol Gastroenterol. 2021 Mar;45(2):101464. doi: 10.1016/j.clinre.2020.05.012. Epub 2020 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping anticancer drugs near the tumor. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether chemoembolization is more effective with or without sunitinib malate in treating patients with liver cancer.\n\nPURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization of the liver and to see how well in works when given together with or without sunitinib malate in treating patients with liver cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To evaluate unacceptable bleeding or hepatic failure at 10 weeks post-treatment in patients with unresectable hepatocellular carcinoma treated with transarterial chemoembolization in combination with sunitinib malate versus transarterial chemoembolization alone.\n* To evaluate the overall survival of these patients.\n\nSecondary\n\n* To evaluate the tumor stabilization rate in these patients.\n* To evaluate the safety of this regimen in these patients.\n* To evaluate the disease-free survival of these patients.\n* To evaluate the relapse-free survival of these patients.\n* To evaluate the quality of life of these patients.\n* To evaluate the overall survival rate at 2 years of these patients.\n\nOUTLINE: This is a multicenter study.\n\nPilot: Patients receive oral sunitinib malate once daily on days 1-28. Beginning 7-10 days later, patients undergo 1-3 courses of transarterial chemoembolization (TACE). Treatment repeats every 6 weeks for 1 year.\n\nRandomization: Patients are stratified according to main tumor diameter (\\< 5 cm vs ≥ 5 cm), nodular involvement (uninodular vs multinodular), and center. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive sunitinib malate and TACE as in the pilot phase.\n* Arm II: Patients receive oral placebo once daily on days 1-28 and TACE as in the pilot phase.\n\nQuality of life is assessed periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed hepatocellular carcinoma or liver tumor responding to the Barcelona criteria\n* Child-Pugh score of 5-6 (Class A)\n* Tumor suitable for transarterial chemoembolization (one or more planned courses allowed)\n* Tumor not suitable for surgical resection\n* No extrahepatic metastases, including cerebral metastases\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Absolute neutrophil count ≥ 1.5 x 10\\^9/L\n* Platelet count ≥ 100 x 10\\^9/L\n* Hemoglobin ≥ 10 g/dL\n* PT ≥ 50%\n* Creatinine ≤ 120 μmol/L\n* Bilirubin normal\n* ALT/AST ≤ 3.5 times upper limit of normal (ULN)\n* Alkaline phosphatases ≤ 4 times ULN\n* Fibrinogen ≥ 1.5 g/L\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No portal vein thrombosis\n* Able to comply with scheduled follow-up and management of toxicity\n* No uncontrolled hypertension or requiring ≥ 2 classes of antihypertensive drugs\n* No concomitant disease or uncontrolled severe disease\n* No contraindications to the vascular occlusion procedure\n* No prior or concurrent malignancy within the past 5 years, except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell carcinoma of the skin\n* No psychiatric disability or social, family, or geographic reason for which the patient may not be followed regularly\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 7 days since prior CYP3A4 inhibitors or inducers\n* At least 3 months since prior radiofrequency ablation\n* No prior chemotherapy\n* No prior sunitinib, sorafenib, or any other inhibitors of angiogenesis\n* No concurrent participation in another trial'}, 'identificationModule': {'nctId': 'NCT01164202', 'acronym': 'SATURNE', 'briefTitle': 'Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Federation Francophone de Cancerologie Digestive'}, 'officialTitle': 'A Double-Blind, Randomized, Phase II/III Study Comparing the Use of Chemoembolization Combined With Sunitinib Against Chemoembolization Combined With a Placebo in Patients With Hepatocellular Carcinoma (SATURNE)', 'orgStudyIdInfo': {'id': 'PRODIGE 16'}, 'secondaryIdInfos': [{'id': 'FFCD-PRODIGE-16'}, {'id': 'FFCD-0905'}, {'id': 'EUDRACT-2009-017064-16'}, {'id': 'EU-21050'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo 3cps/days 4 weeks over 6 during 1 year', 'interventionNames': ['Drug: Placebo', 'Procedure: transarterial chemoembolization']}, {'type': 'EXPERIMENTAL', 'label': 'Sunitinib', 'description': 'sunitinib (SUTENT®) 37,5 mg/d (3 cps of 12,5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year', 'interventionNames': ['Drug: sunitinib malate', 'Procedure: transarterial chemoembolization']}], 'interventions': [{'name': 'sunitinib malate', 'type': 'DRUG', 'description': 'placebo 3cps/days 4 weeks over 6 during 1 year', 'armGroupLabels': ['Sunitinib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo 3cps/days 4 weeks over 6 during 1 year', 'armGroupLabels': ['Placebo']}, {'name': 'transarterial chemoembolization', 'type': 'PROCEDURE', 'description': 'Chimioembolisation', 'armGroupLabels': ['Placebo', 'Sunitinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'CHU Nord', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Annecy', 'country': 'France', 'facility': 'CHR', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Avignon', 'country': 'France', 'facility': 'Institut Sainte Catherine', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Besançon', 'country': 'France', 'facility': 'CHU J Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Béziers', 'country': 'France', 'facility': 'CH', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU Côte de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Cornebarrieu', 'country': 'France', 'facility': 'Clinique des Cèdres', 'geoPoint': {'lat': 43.64967, 'lon': 1.32588}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Guilherand-Granges', 'country': 'France', 'facility': 'CH', 'geoPoint': {'lat': 44.93278, 'lon': 4.87372}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'country': 'France', 'facility': 'Hopital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lorient', 'country': 'France', 'facility': 'CHBS', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Privé Jean Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CH Ambroise Paré', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CH Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CHU La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Saint Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHRU Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nice', 'country': 'France', 'facility': "CHU -Hôpital de l'Archet II", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Orléans', 'country': 'France', 'facility': 'CHR', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Paris St Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Jean Bernard', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Reims', 'country': 'France', 'facility': 'CHU Robert Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CAC', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Mohamed Hebbar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospital Universitaire Hop Huriez'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federation Francophone de Cancerologie Digestive', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}