Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 4:13 AM
Study NCT ID:
NCT00503867
Status:
TERMINATED
Last Update Posted:
2020-12-10
First Post:
2007-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dcade@sirtex.com', 'phone': '011 61 2 9964 8470', 'title': 'Medical Director', 'organization': 'Sirtex Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From consent until 24 weeks post last dose of protocol chemotherapy.', 'eventGroups': [{'id': 'EG000', 'title': 'SIR-Spheres Microspheres', 'description': 'Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'International Normalised Radio Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events Grade 3 or Higher', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SIR-Spheres Microspheres', 'description': 'Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of enrollment until the date of death from any cause assessed up 24 weeks.', 'description': 'Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population - all patients who received initial SIRT treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SIR-Spheres Microspheres', 'description': 'Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.'}], 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not assessed as no data was collected prior to termination of the study.'}, {'type': 'SECONDARY', 'title': 'Tumor Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SIR-Spheres Microspheres', 'description': 'Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.'}], 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.', 'description': 'Tumour response rates estimated by the proportion of patients with a best response of CR, PR or SD by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) with corresponding exact 90% confidence limits being reported. Per RECIST v1.0 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not assessed as no data was collected prior to termination of the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SIR-Spheres Microspheres', 'description': 'Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.'}], 'timeFrame': '52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not assessed as no data was collected prior to termination of the study.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SIR-Spheres Microspheres', 'description': 'Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.'}], 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.', 'description': 'Overall Survival is defined as the time interval between the date of enrollment and the date of death from any cause.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not assessed as no data was collected prior to termination of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SIR-Spheres Microspheres', 'description': 'Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Three medical centers in the US enrolled 10 patients from July 18, 2007 to March 9, 2010.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hepatic Arterial Radioembolization SIR-Spheres Microspheres', 'description': 'SIR-Spheres microspheres\n\nSIR-Spheres microspheres: SIR-Spheres Yttrium-90 microspheres'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'groupId': 'BG000', 'lowerLimit': '47.5', 'upperLimit': '80.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG performance status', 'classes': [{'categories': [{'title': '0 (full activity)', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '1 (ambulatory restricted)', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'unitOfMeasure': 'Participants'}, {'title': 'Previous chemotherapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '1 cycle Nexavar, 800 mg BID', 'unitOfMeasure': 'Participants'}, {'title': 'Previous radiotherapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease characteristics', 'classes': [{'title': 'Okuda Stage 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'CLIP score Class 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'CLIP score Class 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'CLIP score Class Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Cirrhosis (Yes)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Cirrhosis (No)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'TNM Classification of Primary Tumor, T2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'TNM Classification of Primary Tumor, T3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'TNM Classification of Primary Tumor, T4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'TNM Classification of regional lymph nodes (No)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Hepatitis B (Yes)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Hepatitis B (No)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Hepatitis C (Yes)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Hepatitis C (No)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Metabolic Liver Disease (No)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'History of alcohol abuse (Yes)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'History of alcohol abuse (No)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Hepatocellular carcinoma staging systems to determine prognosis included Okuda Staging, Cancer of the Liver Italian Program \\[CLIP\\]) \\& tumor node metastasis (TNM) classification. Higher grades/score classes correlate to poorer prognosis.\n\nOkuda classification include cancer-related variables and liver function variables (Grade 1 to 3).\n\nCLIP staging combines Child-Pugh score with tumour criteria: morphology, portal invasion, \\& alpha fetoprotein levels. (Stage 0 to 6).\n\nTNM staging describe size and/or extension of the primary tumor (Grade 1 to 4).', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Low patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2010-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2007-07-18', 'resultsFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2007-07-18', 'lastUpdatePostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-16', 'studyFirstPostDateStruct': {'date': '2007-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events Grade 3 or Higher', 'timeFrame': 'From date of enrollment until the date of death from any cause assessed up 24 weeks.', 'description': 'Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.'}], 'secondaryOutcomes': [{'measure': 'Time to Disease Progression', 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.'}, {'measure': 'Tumor Response Rate', 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.', 'description': 'Tumour response rates estimated by the proportion of patients with a best response of CR, PR or SD by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) with corresponding exact 90% confidence limits being reported. Per RECIST v1.0 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}, {'measure': 'Change From Baseline in Health-related Quality of Life', 'timeFrame': '52 weeks'}, {'measure': 'Overall Survival', 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.', 'description': 'Overall Survival is defined as the time interval between the date of enrollment and the date of death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unresectable hepatocellular carcinoma', 'HCC', 'SIR-Spheres', 'Y-90 Microspheres', 'brachytherapy', 'Selective Internal Radiation Therapy (SIRT)', 'liver cancer'], 'conditions': ['Carcinoma, Hepatocellular', 'Hepatoma']}, 'descriptionModule': {'briefSummary': "The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient's quality of life, and if and how the cancer responds to the treatment.", 'detailedDescription': 'This study is a multi-institutional, non-randomized pilot study that aims to assess the safety and toxicity of hepatic arterial radioembolization using SIR-Spheres yttrium-90 microspheres (SIR-Spheres microspheres) in the treatment of patients with unresectable primary hepatocellular carcinoma (HCC). The study aims to recruit 40 patients over a period of 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must have a confirmed diagnosis of HCC.\n* at least 18 years of age.\n* must have a confirmed diagnosis of HCC either by histological confirmation or, in a subject who exhibits a vascular liver mass in the presence of radiographically apparent cirrhosis, an alpha-fetoprotein (AFP) level greater than 500 International Units/milliliter (UI/ml).\n* must present HCC that is not amenable to surgical resection or immediate liver transplantation, or that is not optimally treatable with local ablative techniques such as radio-frequency ablation due to its size, extent or presence of cirrhosis.\n* must present measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 10 mm with spiral CT scan or greater than or equal to 20 mm using conventional techniques (CT, MRI).\n* must present with a whole-liver tumor burden of greater than or equal to 15% and less than or equal to 70%\n* must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.\n* must have normal organ and marrow function\n\nExclusion criteria:\n\nIncludes both the listed contraindications to SIR-Spheres® and the exclusion criteria specific to the setting of this investigational study:\n\n* hepatic artery directed therapy within the previous 6 months.\n* chemotherapy within the previous 4 weeks\n* have not recovered from adverse events due to agents administered previously\n* Prior external hepatic radiation therapy for HCC, more than two prior systemic chemotherapy regimes for HCC or any other concomitant therapy for HCC\n* Currently receiving any other investigational agents for the treatment of their cancer.\n* Any extra-hepatic metastases other than metastatic disease found in the lung, bone and/or abdominal lymph nodes that are not otherwise life limiting.\n* Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.\n* Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.\n* Any of the following contraindications to angiography and selective visceral catheterization:\n\n * Bleeding diathesis\n * Severe peripheral vascular disease\n * Portal hypertension with hepatofugal flow\n* Female subjects who are pregnant or currently breastfeeding.\n* Refusal or inability to use effective means of contraception in men or women of childbearing potential.\n* Current enrollment in any other investigational drug or device study.'}, 'identificationModule': {'nctId': 'NCT00503867', 'briefTitle': 'SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sirtex Medical'}, 'officialTitle': 'A Pilot Study of Yttrium-90 Microspheres (SIR-Spheres®) Therapy for the Treatment of Unresectable Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'STX 0106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SIR-Spheres microspheres', 'description': 'SIR-Spheres microspheres', 'interventionNames': ['Device: SIR-Spheres microspheres']}], 'interventions': [{'name': 'SIR-Spheres microspheres', 'type': 'DEVICE', 'description': 'SIR-Spheres Yttrium-90 microspheres', 'armGroupLabels': ['SIR-Spheres microspheres']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University - Kimmel Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Liver Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'The Liver Institute at Methodist Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ravi Murthy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}, {'name': 'T. Clark Gamblin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPMC Liver Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Originally there was a plan to share the data with the Data Monitoring Committee, however the study was closed early due to lack of enrollment and the Data Monitoring Committee did not convene.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sirtex Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}