Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-25 @ 6:39 PM
Study NCT ID:
NCT01899261
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2013-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nohri@montefiore.org', 'phone': '718-920-7750', 'title': 'Dr. Nitin Ohri', 'organization': 'Montefiore Medical Center and Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment (SBRT)', 'description': 'Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.\n\nStereotactic Radiosurgery: Undergo SBRT', 'otherNumAtRisk': 20, 'otherNumAffected': 8, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'notes': 'Grade 1 fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'Grade 1 nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'notes': 'Grade 1 thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'notes': 'Grade 1 abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'notes': 'Grade 1 dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severe Treatment-related Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (SBRT)', 'description': 'Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.\n\nStereotactic Radiosurgery: Undergo SBRT'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 3 months of SBRT', 'description': 'The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cancer Specific Survival (CSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (SBRT)', 'description': 'Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.\n\nStereotactic Radiosurgery: Undergo SBRT'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from study entry to death from Hepatocellular Carcinoma (HCC) progression, assessed up to 2 years', 'description': 'Cancer Specific Survival (CSS) was assessed in patients who were diagnosed with HCC and treated with liver SBRT as the percentage of patients with Cause-Specific Death from HCC. Patients alive at the end of the follow-up period were censored. Competing risk analysis was performed.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (SBRT)', 'description': 'Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.\n\nStereotactic Radiosurgery: Undergo SBRT'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from study entry to death from any cause, assessed up to 2 years', 'description': 'Overall Survival, estimated using the Kaplan-Meier method, reflected the percentage of patients who were were diagnosed with HCC and started SBRT treatment and were still alive at the conclusion of the study.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Local Progression (TTLP) of Treated Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (SBRT)', 'description': 'Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.\n\nStereotactic Radiosurgery: Undergo SBRT'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '11'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of first treatment dose to the first date of objective local progressive disease as defined by RECIST criteria, assessed up to 2 years', 'description': 'Time to Local progression (TTLP) of treated lesions in HCC patients after liver SBRT treatment was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST). For patients who died from the study disease without progression of the radiated lesion, time to local progression was censored at the date of death. For patients not known to have died as of the data cut-off date, and who did not have locally progressive disease, time to local progression was censored at the last progression-free disease assessment.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '2 subjects with local progression after Stereotactic Body Radiation Therapy (SBRT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (SBRT)', 'description': 'Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.\n\nStereotactic Radiosurgery: Undergo SBRT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (SBRT)', 'description': 'Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.\n\nStereotactic Radiosurgery: Undergo SBRT'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', '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': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Child-Pugh Score', 'classes': [{'categories': [{'title': '5', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '6', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '7', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Child-Pugh score employs five clinical measures of liver disease: total bilirubin, serum albumin, prothrombin time, ascites, and hepatic encephalopathy. Each measure is scored 1-3, with 3 indicating most severe derangement. The total score therefore ranges from 5 to 15.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-12', 'studyFirstSubmitDate': '2013-07-11', 'resultsFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2013-07-11', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-19', 'studyFirstPostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe Treatment-related Toxicity', 'timeFrame': 'Within 3 months of SBRT', 'description': 'The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0'}], 'secondaryOutcomes': [{'measure': 'Cancer Specific Survival (CSS)', 'timeFrame': 'Time from study entry to death from Hepatocellular Carcinoma (HCC) progression, assessed up to 2 years', 'description': 'Cancer Specific Survival (CSS) was assessed in patients who were diagnosed with HCC and treated with liver SBRT as the percentage of patients with Cause-Specific Death from HCC. Patients alive at the end of the follow-up period were censored. Competing risk analysis was performed.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Time from study entry to death from any cause, assessed up to 2 years', 'description': 'Overall Survival, estimated using the Kaplan-Meier method, reflected the percentage of patients who were were diagnosed with HCC and started SBRT treatment and were still alive at the conclusion of the study.'}, {'measure': 'Time to Local Progression (TTLP) of Treated Lesions', 'timeFrame': 'From date of first treatment dose to the first date of objective local progressive disease as defined by RECIST criteria, assessed up to 2 years', 'description': 'Time to Local progression (TTLP) of treated lesions in HCC patients after liver SBRT treatment was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST). For patients who died from the study disease without progression of the radiated lesion, time to local progression was censored at the date of death. For patients not known to have died as of the data cut-off date, and who did not have locally progressive disease, time to local progression was censored at the last progression-free disease assessment.'}]}, 'conditionsModule': {'conditions': ['Adult Hepatocellular Carcinoma', 'Advanced Adult Hepatocellular Carcinoma', 'Localized Non-Resectable Adult Liver Carcinoma', 'Recurrent Adult Liver Carcinoma']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT.\n\nII. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT.\n\nIII. To evaluate explanted irradiated liver tissue (for patients who proceed to liver transplantation) to determine extent of residual tumor and extent of radiation effects within and around the irradiated field.\n\nOUTLINE:\n\nPatients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months for up to 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Life expectancy \\> 3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2\n* HCC diagnosed by either of the following approaches:\n\n * Histologic confirmation of HCC on biopsy\n * Evidence of vascular enhancement of suspected lesion on at least two imaging techniques\n * Evidence of vascular enhancement on a single technique if the alpha-fetoprotein (AFP) is \\> 200 ng/mL in the setting of cirrhosis or chronic hepatitis B/C\n* HCC must be deemed unresectable by an experienced surgeon or patient must be medically inoperable or extra-hepatic metastases must be present (making resection an inappropriate treatment option) or patient must have declined the option of surgery after consultation with a surgeon\n\n * Barcelona Clinic Liver Cancer score of B or C required (i.e., intermediate or advanced stage HCC)\n* Prior liver resection or ablative therapy is permitted\n* Prior transarterial chemoembolization (TACE) is permitted\n* Patients must have recovered from the effects of previous therapy\n* Maximal tumor size of 15 cm and \\> 700 cc of uninvolved liver\n* Hemoglobin \\> 9.0 g/L\n* Absolute neutrophil count \\>= 1.0 bil/L\n* Platelets \\>= 70,000 bil/L\n* Total bilirubin \\< 2 mg/dL\n* International normalized ratio (INR) =\\< 1.5 or correctable with vitamin K (higher INR acceptable if patient is on Coumadin)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\\< 6 times upper range of normal\n\nExclusion Criteria:\n\n* Active hepatitis or encephalopathy related to liver failure\n* Prior radiation therapy to the upper abdomen or thorax\n* Lesions within 1 cm from the stomach\n* Prior uncontrolled, life threatening malignancy within the previous 6 months\n* Pregnancy is not permitted; women of child-bearing age must undergo pregnancy testing prior to enrollment\n* Previous gastric, duodenal or variceal bleed within the past 2 months\n* Thrombolytic therapy within 4 weeks or commencement of anticoagulant use within the past 3 months'}, 'identificationModule': {'nctId': 'NCT01899261', 'briefTitle': 'Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '2010-326'}, 'secondaryIdInfos': [{'id': '2010-326', 'type': 'OTHER', 'domain': 'Albert Einstein College of Medicine'}, {'id': 'P30CA013330', 'link': 'https://reporter.nih.gov/quickSearch/P30CA013330', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (SBRT)', 'description': 'Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.', 'interventionNames': ['Radiation: Stereotactic Radiosurgery']}], 'interventions': [{'name': 'Stereotactic Radiosurgery', 'type': 'RADIATION', 'otherNames': ['Stereotactic External Beam Irradiation', 'stereotactic external-beam radiation therapy', 'Stereotactic Radiation Therapy', 'Stereotactic Radiotherapy', 'stereotaxic radiation therapy', 'stereotaxic radiosurgery'], 'description': 'Undergo SBRT', 'armGroupLabels': ['Treatment (SBRT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Nitin Ohri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nitin Ohri', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}