Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-28 @ 3:35 AM
Study NCT ID:
NCT01151761
Status:
TERMINATED
Last Update Posted:
2016-07-29
First Post:
2010-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}, {'id': 'D005706', 'term': 'Gallbladder 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'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dtchang@stanford.edu', 'phone': '650-724-3547', 'title': 'Dr. Daniel Chang', 'organization': 'Stanford University Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to low accrual.'}}, 'adverseEventsModule': {'timeFrame': 'The entire period of the study, 2 years', 'eventGroups': [{'id': 'EG000', 'title': 'SBRT, Chemotherapy and Liver Transplantation', 'description': 'The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Hepatic failure (encephalopathy)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V4'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT and Chemo', 'description': 'The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'months', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.5', 'ciLowerLimit': '7', 'ciUpperLimit': '10', 'estimateComment': 'There were only two patients in the study. Both died without having any local failure. One patient died at 10 months, the other at 7 months. The range for the 95%CI is both the full range and the 95%CI.', 'groupDescription': 'The median Progression Free Survival (PFS) time as calculated using Kaplan Meier methodology. For PFS both death and progression are counted as events.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Progression free survival is defined to be the time to progression of disease or death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pathologic Complete Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT and Chemo', 'description': 'The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum CA 19-9 Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT and Chemo', 'description': 'The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '3329.1', 'groupId': 'OG000', 'lowerLimit': '62.2', 'upperLimit': '6596'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Initial level of Cancer antigen 19-9', 'unitOfMeasure': 'U/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT and Chemo', 'description': 'The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'the estimated probability for the percentage of participants with overall survival at 12 months.', 'unitOfMeasure': 'probability', 'reportingStatus': 'POSTED', 'populationDescription': 'There were only two patients analyzed. Please take that under advisement when looking at the results.'}, {'type': 'SECONDARY', 'title': 'Liver Transplant Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT and Chemo', 'description': 'The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Freedom From Local Progression at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT and Chemo', 'description': 'The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'proportion of participants', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0', 'estimateComment': 'None of the two patients who participated had a local recurrence before they died.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Neither of the two patients that participated in the study had a local recurrence prior to dying.'}, {'type': 'SECONDARY', 'title': 'Liver Transplant Conversion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT and Chemo', 'description': 'The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The ability to successfully perform liver transplant among patients who initially have tumor \\>3 cm', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Time to Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT and Chemo', 'description': 'The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SBRT, Chemotherapy and Liver Transplantation', 'description': 'The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The location is the Stanford Cancer Center. The study was open to accrual 1/18/2011. The study closed on 9/28/2012.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SBRT, Chemotherapy and Liver Transplantation', 'description': 'The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '9.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-30', 'studyFirstSubmitDate': '2010-06-15', 'resultsFirstSubmitDate': '2013-07-03', 'studyFirstSubmitQcDate': '2010-06-25', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-20', 'studyFirstPostDateStruct': {'date': '2010-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival at 12 Months', 'timeFrame': '12 months', 'description': 'Progression free survival is defined to be the time to progression of disease or death.'}], 'secondaryOutcomes': [{'measure': 'Pathologic Complete Response Rate', 'timeFrame': '12 months', 'description': 'Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.'}, {'measure': 'Serum CA 19-9 Levels', 'timeFrame': '12 months', 'description': 'Initial level of Cancer antigen 19-9'}, {'measure': 'Overall Survival at 12 Months', 'timeFrame': '12 months', 'description': 'the estimated probability for the percentage of participants with overall survival at 12 months.'}, {'measure': 'Liver Transplant Rate', 'timeFrame': '12 months', 'description': 'The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm'}, {'measure': 'Freedom From Local Progression at 12 Months', 'timeFrame': '12 months', 'description': 'the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk'}, {'measure': 'Liver Transplant Conversion Rate', 'timeFrame': '12 months', 'description': 'The ability to successfully perform liver transplant among patients who initially have tumor \\>3 cm'}, {'measure': 'Median Time to Overall Survival', 'timeFrame': '18 months', 'description': 'The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cholangiocarcinoma', 'Hepatobiliary Neoplasm', 'Liver Cancer', 'Bile Duct Cancer', 'Cancer of Gallbladder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine progression-free survival at 12 months for stereotactic body radiotherapy (SBRT) and chemotherapy for unresectable hilar cholangiocarcinoma (CCA).', 'detailedDescription': 'Investigators hope to learn more about neoadjuvant SBRT and chemotherapy for unresectable CCA, and if SBRT followed by chemotherapy can lead to successful liver transplantation. This knowledge is important for this patient group as this disease is a highly lethal malignancy that often presents as unresectable, however surgery or transplantation are the only curative options.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cholangiocarcinoma by any of the below:\n\n * Positive transcatheter biopsy or brush cytology\n * CA 19-9 \\≥ 100mg/mL with a malignant-appearing stricture on cholangiography\n * Biliary ploidy by fluorescent in situ hybridization with a malignant stricture on cholangiography\n* Liver tumors not to exceed 8 cm in greatest axial dimension (800 cc of uninvolved liver)\n* Unresectable tumor above cystic duct\n* Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure by any of the below:\n\n * Bilateral segmental ductal extension\n * Encasement of the main portal vein\n * Unilateral segmental ductal extension with contralateral vascular encasement\n * Unilateral atrophy with either contralateral segmental ductal or vascular (hepatic artery, portal vein) involvement\n* Ascites is allowed if the Model for End-Stage Liver Disease (MELD) score is \\<15\\[1\\]\n* Age \\> 18 years old\n* Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix 1)\n* Lab values within 2 wks prior to randomization:\n\n * See STUDY SCHEMA for specific blood count inclusion criteria: ANC \\≥ 500 x 109/L (\\≥ 1500/mm3), Platelets \\≥ 5 x 109/L (\\≥ 50,000/mm3), Hgb \\≥ 9g/dL\n * Adequate liver function: Total bilirubin \\≤1.5 x upper limit of normal (ULN); ALT and/or AST \\& alkaline phosphatase \\≤ 5 x ULN.\n * Adequate biliary drainage, with no evidence of active uncontrolled infection (patients on antibiotics are eligible).\n * See STUDY SCHEMA for specific renal function inclusion criteria: Adequate renal function with a calculated GFR \\≥ 40 ml/min. If the calculated GFR is below 40 ml/min a 24 hour urine creatinine clearance can be used.\n * Albumin \\> 2.5 mg/dL\n * INR \\≤ 1.5\n* Life expectancy \\> 6 months\n* Capable of giving written informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to the upper abdomen\n* Contraindication to receiving radiotherapy\n* Prior chemotherapy\n* Prior biliary resection or attempted resection\n* Prior transperitoneal biopsy\n* Large esophageal varices without band ligation\n* Active GI bleed or within 2 weeks of study enrollment\n* Ascites refractory to medical therapy or shunting\n* Active/unresolved biliary tract obstruction\n* Presence of multifocal, lymphatic, or extrahepatic metastases\n* Participation in another concurrent treatment protocol\n* If history of other primary cancer, subject eligible only if she or he has:\n\n * Curatively resected non-melanomatous skin cancer\n * Curatively treated cervical carcinoma in situ\n * Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years\n* Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial\n* Any psychiatric or other disorder (eg brain metastases) likely to impact on informed consent\n* Pregnancy or breast-feeding\n* While not excluded, patients with significant impaired hearing must be made aware of potential ototoxicity and may choose not to be included. If included, baseline audiograms are recommended and, in those given cisplatin, should be followed by repeat audiograms prior to cycle 2.'}, 'identificationModule': {'nctId': 'NCT01151761', 'briefTitle': 'Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Phase II Study of Stereotactic Body Radiotherapy (SBRT) and Chemotherapy for Unresectable Cholangiocarcinoma Followed by Liver Transplantation', 'orgStudyIdInfo': {'id': 'HEP0032'}, 'secondaryIdInfos': [{'id': 'HEP0032', 'type': 'OTHER', 'domain': 'Stanford University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBRT, Chemo and Liver Transplantation', 'description': 'The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU', 'interventionNames': ['Procedure: Stereotactic Body Radiotherapy', 'Drug: Gemcitabine', 'Drug: Cisplatin', 'Drug: Carboplatin', 'Drug: Capecitabine', 'Drug: 5FU', 'Procedure: Liver transplantation']}], 'interventions': [{'name': 'Stereotactic Body Radiotherapy', 'type': 'PROCEDURE', 'otherNames': ['External photon radiation'], 'description': 'Standard of care', 'armGroupLabels': ['SBRT, Chemo and Liver Transplantation']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': '100 mg/m2, IV', 'armGroupLabels': ['SBRT, Chemo and Liver Transplantation']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Platinol', 'Platinol-AQ'], 'description': '25 mg/m2, IV', 'armGroupLabels': ['SBRT, Chemo and Liver Transplantation']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin', 'Paraplatin-AQ'], 'description': 'AUC 2, based on Calvert formula, IV', 'armGroupLabels': ['SBRT, Chemo and Liver Transplantation']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': '1000 mg/m2, PO', 'armGroupLabels': ['SBRT, Chemo and Liver Transplantation']}, {'name': '5FU', 'type': 'DRUG', 'otherNames': ['Fluorouracil', 'Adrucil', 'Carac', 'Efudix', 'Efudex', 'Fluoroplex'], 'description': '200 mg/m2', 'armGroupLabels': ['SBRT, Chemo and Liver Transplantation']}, {'name': 'Liver transplantation', 'type': 'PROCEDURE', 'armGroupLabels': ['SBRT, Chemo and Liver Transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Daniel T Chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Daniel T. Chang', 'investigatorAffiliation': 'Stanford University'}}}}