Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT00456612
Status:
TERMINATED
Last Update Posted:
2017-03-06
First Post:
2007-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Radiosurgery for Glioblastoma Multiforme
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, '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': 'amahadev@bidmc.harvard.edu', 'phone': '617-667-2345', 'title': 'Anand Mahadevan, MD', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination due to difficulty in recruitment and retaining due to extremely bad prognosis of disease'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Single Arm Study', 'description': 'Single arm Phase II Study', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percent Progression -Free Survival at 6 Months Will be Tabulated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyberknife', 'description': 'Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.\n\nCyberKnife: Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.'}], 'timeFrame': '6 months', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.', 'timeFrame': '1year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Single arm Phase II Study'}], 'timeFrame': 'consent to prgression or death', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cyberknife', 'description': 'Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm', 'description': 'Single arm Phase II Study'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2007-04-04', 'resultsFirstSubmitDate': '2011-06-22', 'studyFirstSubmitQcDate': '2007-04-04', 'lastUpdatePostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-03', 'studyFirstPostDateStruct': {'date': '2007-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percent Progression -Free Survival at 6 Months Will be Tabulated', 'timeFrame': '6 months'}, {'measure': 'Progression Free Survival', 'timeFrame': 'consent to prgression or death'}], 'secondaryOutcomes': [{'measure': 'Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.', 'timeFrame': '1year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glioblastoma Multiforme']}, 'descriptionModule': {'briefSummary': 'Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS\\<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.\n\nTo assess the tolerability of Cyberknife Radiosurgery for High Grade Gliomas in Elderly with poor performance status.\n\nSecondary:\n\nAssessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime.', 'detailedDescription': 'Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS\\<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '66 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy.\n2. Patient must recover from the effects of surgery, post-operative infection, or other complications.\n3. Therapy should start within 5 weeks of surgery\n4. Must have an estimated survival of \\> 8 weeks.\n5. KPS \\< 70.\n6. Age \\> 65 years.\n7. Must have a pre- and post operative contrast enhanced MRI scans\n8. Laboratory values within the following limits: ANC (absolute neutrophil count) \\>/= 1500 cell/ul Platelets \\>/= 100x 10(3)/ul, Hemoglobin \\>/= 9g/dl, Serum Creatinine ≤ 1.5mg/dl., Serum total Bilirubin \\</= 1.5 x upper limit of normal (ULN), SGOT/SGPT \\</= 2.5x ULN, Albumin \\>/= 3g/dl.\n\n \\-\n\nExclusion Criteria:\n\n1. Histology grade less than Anaplastic Glioma ( WHO Grade III).\n2. Recurrent malignant glioma.\n3. Tumor involving the Brain stem.\n4. Any detected tumor foci beyond the cranial vault.\n5. Major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy.\n6. Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of uterus, cervix or bladder, unless disease free for \\> 5 years.\n7. Prior chemotherapy for the current disease.\n\n \\-"}, 'identificationModule': {'nctId': 'NCT00456612', 'briefTitle': 'Radiosurgery for Glioblastoma Multiforme', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status', 'orgStudyIdInfo': {'id': '2006P-000464'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cyberknife', 'description': 'Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.', 'interventionNames': ['Procedure: CyberKnife']}], 'interventions': [{'name': 'CyberKnife', 'type': 'PROCEDURE', 'description': 'Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.', 'armGroupLabels': ['Cyberknife']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Anand Mahadevan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Anand Mahadevan', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}