Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-30 @ 7:44 PM
Study NCT ID:
NCT01347333
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2011-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Body Radiotherapy for Liver Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}], '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': 'michelle.mcfarland@mercy.net', 'phone': '314-251-8827', 'title': 'Michelle McFarland, MPH, CHRC', 'organization': 'Mercy Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 years', 'description': 'At risk for primary liver tumor is 0 because no patients were enrolled to this group.', 'eventGroups': [{'id': 'EG000', 'title': 'Liver Metastases', 'description': 'Oligometastases (1-3) with aggregate tumor diameter \\< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes\n\nStereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Primary Liver Tumors', 'description': 'Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma\n\nStereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Local Tumor Recurrence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Metastases', 'description': 'Oligometastases (1-3) with aggregate tumor diameter \\< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes\n\nStereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)'}, {'id': 'OG001', 'title': 'Primary Liver Tumors', 'description': 'Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma\n\nStereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients enrolled into primary liver tumor group.'}, {'type': 'SECONDARY', 'title': 'Late Complication Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Metastases', 'description': 'Oligometastases (1-3) with aggregate tumor diameter \\< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes\n\nStereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)'}, {'id': 'OG001', 'title': 'Primary Liver Tumors', 'description': 'Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma\n\nStereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)'}], 'timeFrame': '5 years', 'description': 'Toxicities will be assessed using CTCAE grading criteria at specified timepoints.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liver Metastases', 'description': 'Oligometastases (1-3) with aggregate tumor diameter \\< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes\n\nStereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)'}, {'id': 'FG001', 'title': 'Primary Liver Tumors', 'description': 'Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma\n\nStereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'comment': 'No participants were enrolled in the Primary Liver Tumor arm.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liver Metastases', 'description': 'Oligometastases (1-3) with aggregate tumor diameter \\< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes\n\nStereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)'}, {'id': 'BG001', 'title': 'Primary Liver Tumors', 'description': 'Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma\n\nStereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '79'}, {'value': '63', 'groupId': 'BG002', 'lowerLimit': '47', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'No patients were analyzed in primary liver tumors because none were enrolled to that group.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2011-05-02', 'resultsFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2011-05-03', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-19', 'studyFirstPostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Tumor Recurrence Rate', 'timeFrame': '5 years', 'description': 'Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.'}], 'secondaryOutcomes': [{'measure': 'Late Complication Rates', 'timeFrame': '5 years', 'description': 'Toxicities will be assessed using CTCAE grading criteria at specified timepoints.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['liver metastases', 'stereotactic radiotherapy'], 'conditions': ['Liver Metastases', 'Hepatocellular Carcinoma', 'Intrahepatic Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.', 'detailedDescription': "This study is a single site, non-randomized, prospective, phase IV trial.\n\nComposed of 4 patient groups:\n\n1. Oligometastases (1-3) with aggregate tumor diameter \\< 6 cm\n2. Metastases from neuroendocrine tumors with functional endocrine syndromes\n3. Unresectable hepatocellular carcinoma (HCC)\n4. Unresectable intrahepatic cholangiocarcinoma (IHCC) Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age \\>= 18 years\n* Zubrod performance status of 0-3\n* Oligometastases (1-3) with aggregate tumor diameter \\< 6 cm\n* Metastases from neuroendocrine tumors with functional endocrine syndromes for symptom palliation\n* Unresectable hepatocellular carcinoma (HCC)\n* Unresectable intrahepatic cholangiocarcinoma (IHCC)\n* Maximum tumor diameter \\< 6 cm\n* Adequate liver function:\n\nTotal bilirubin \\< 3 mg/dL Serum albumin \\> 2.5 g/dL Serum levels of liver enzymes \\< 3 times the upper limit of normal Normal PT and PTT unless patient is receiving anticoagulant medication\n\n\\- Signed study-specific consent form\n\nExclusion Criteria:\n\n* Maximum tumor diameter \\> 6 cm\n* Prior radiotherapy to the liver\n* Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females\n* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent'}, 'identificationModule': {'nctId': 'NCT01347333', 'briefTitle': 'Stereotactic Body Radiotherapy for Liver Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Research'}, 'officialTitle': 'Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors', 'orgStudyIdInfo': {'id': '08-045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'liver metastases', 'description': 'Oligometastases (1-3) with aggregate tumor diameter \\< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes', 'interventionNames': ['Radiation: Stereotactic body radiosurgery']}, {'type': 'OTHER', 'label': 'Primary Liver Tumors', 'description': 'Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma', 'interventionNames': ['Radiation: Stereotactic Body Radiotherapy']}], 'interventions': [{'name': 'Stereotactic body radiosurgery', 'type': 'RADIATION', 'description': '36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)', 'armGroupLabels': ['liver metastases']}, {'name': 'Stereotactic Body Radiotherapy', 'type': 'RADIATION', 'description': '26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)', 'armGroupLabels': ['Primary Liver Tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Mercy Medical Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Bethany G Sleckman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mercy Hospital St. Louis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Kathy Baglan, MD', 'investigatorAffiliation': 'Mercy Research'}}}}