Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-02-22 @ 3:24 AM
Study NCT ID:
NCT00983359
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2009-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Mario.Ammirati@osumc.edu', 'phone': '614-293-1970', 'title': 'Mario Ammirati, MD', 'organization': 'The Ohio State University Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'The NCI Common Terminology Criteria for Adverse Events version 3 \\[CTCAEv3\\] was used to access adverse events for patients.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Conformal Stereotactic Radiation Therapy)', 'description': 'Patients undergo conformal stereotatic radiation\n\nRadiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Conformal Stereotactic Radiation Therapy)', 'description': 'Patients undergo conformal stereotatic radiation\n\nRadiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Conformal Stereotactic Radiation Therapy)', 'description': 'Patients undergo conformal stereotatic radiation\n\nRadiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years', 'description': "Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered 'censored'. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Neurological Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Conformal Stereotactic Radiation Therapy)', 'description': 'Patients undergo conformal stereotatic radiation\n\nRadiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of enrollment up to 5 years', 'description': "Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered 'censored' observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an 'event' or neurological death.", 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Systemic Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Conformal Stereotactic Radiation Therapy)', 'description': 'Patients undergo conformal stereotatic radiation\n\nRadiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of enrollment up to 5 years', 'description': 'Descriptive analysis will be conducted using Kaplan-Meier survival analysis', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Karnofsky Decay Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Conformal Stereotactic Radiation Therapy)', 'description': 'Patients undergo conformal stereotatic radiation\n\nRadiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of enrollment up to 5 years', 'description': "Time from enrollment to the date the patient's Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient's Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause.", 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Conformal Stereotactic Radiation Therapy)', 'description': 'Patients undergo conformal stereotatic radiation\n\nRadiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Not Eligible for Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patient recruitment period was June 2007 to March 2010'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Conformal Stereotactic Radiation Therapy)', 'description': 'Patients undergo conformal stereotatic radiation\n\nRadiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '≤60', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': '>60', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'patients'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', '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': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'patients'}, {'title': 'Extracranial metastases', 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'patients'}, {'title': 'Number of brain metastases', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': '≥4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients with ≥4 brain metastases were eligible for study if only 1 to 3 were symptomatic and all others asymptomatic.', 'unitOfMeasure': 'patients with brain metastases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2009-09-23', 'resultsFirstSubmitDate': '2016-03-24', 'studyFirstSubmitQcDate': '2009-09-23', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-28', 'studyFirstPostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status', 'timeFrame': 'Up to 5 years', 'description': 'Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to 5 years', 'description': "Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered 'censored'. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident."}, {'measure': 'Time to Neurological Death', 'timeFrame': 'From time of enrollment up to 5 years', 'description': "Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered 'censored' observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an 'event' or neurological death."}, {'measure': 'Time to Systemic Death', 'timeFrame': 'From time of enrollment up to 5 years', 'description': 'Descriptive analysis will be conducted using Kaplan-Meier survival analysis'}, {'measure': 'Karnofsky Decay Time', 'timeFrame': 'From time of enrollment up to 5 years', 'description': "Time from enrollment to the date the patient's Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient's Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tumors metastatic to brain', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Metastatic Cancer', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '24589560', 'type': 'RESULT', 'citation': 'Ammirati M, Kshettry VR, Lamki T, Wei L, Grecula JC. A prospective phase II trial of fractionated stereotactic intensity modulated radiotherapy with or without surgery in the treatment of patients with 1 to 3 newly diagnosed symptomatic brain metastases. Neurosurgery. 2014 Jun;74(6):586-94; discussion 594. doi: 10.1227/NEU.0000000000000325.'}], 'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.\n\nPURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.\n\nSecondary\n\n* To determine the overall survival rate at 6 months.\n* To determine the progression-free survival rate or brain metastases recurrence rate at 6 months.\n* To determine the time to neurological death, time to systemic death, and Karnofsky decay time.\n* To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy.\n\nOUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites.\n\nAfter completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans.\n* Have cancer not originating in central nervous system (CNS)\n* Karnofsky score of at least 60\n* Given written consent\n* At least 18 years of age\n\nExclusion Criteria:\n\n* Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial.\n* Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.'}, 'identificationModule': {'nctId': 'NCT00983359', 'briefTitle': 'Stereotactic Radiation Therapy in Treating Patients With Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases', 'orgStudyIdInfo': {'id': 'OSU-06138'}, 'secondaryIdInfos': [{'id': 'NCI-2011-03139', 'type': 'REGISTRY', 'domain': 'Clinical Trials Reporting Program (CTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (conformal stereotactic radiation therapy)', 'description': 'Patients undergo conformal stereotatic radiation', 'interventionNames': ['Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Radiation'], 'description': 'Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.', 'armGroupLabels': ['Treatment (conformal stereotactic radiation therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Mario Ammirati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mario Ammirati', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}