Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT00802659
Status:
TERMINATED
Last Update Posted:
2014-12-05
First Post:
2008-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
Sponsor:
Organization:
Raw JSON
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patient's pain, and how many side effects participants before have experienced."}, {'id': 'OG001', 'title': 'Group 1', 'description': "1200 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."}, {'id': 'OG002', 'title': 'Group 2', 'description': "1400 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."}, {'id': 'OG003', 'title': 'Group 3', 'description': "1600 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: 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After Stereotactic Irradiation of Spinal Metastases.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group -1', 'description': "1000 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."}, {'id': 'OG001', 'title': 'Group 1', 'description': "1200 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."}, {'id': 'OG002', 'title': 'Group 2', 'description': "1400 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."}, {'id': 'OG003', 'title': 'Group 3', 'description': "1600 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."}], 'timeFrame': '4 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Group 1 was the only group to have a participant enrolled; however this outcome was not measured 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Cancer Therapy - Central Nervous System (FACT-CNS)\n\nParticipant can chose on a scale of 0-4 with 0=not at all and 4=very much.', 'reportingStatus': 'POSTED', 'populationDescription': 'Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group -1', 'description': "1000 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."}, {'id': 'FG001', 'title': 'Group 1', 'description': "1200 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation 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[{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': 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'description': "1400 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."}, {'id': 'BG003', 'title': 'Group 3', 'description': "1600 cGY radiation\n\nStereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Terminated due to low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2008-12-04', 'resultsFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-10', 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field', 'timeFrame': '4 weeks', 'description': 'Optimal dose\n\n1. the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications\n2. the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first'}], 'secondaryOutcomes': [{'measure': 'Duration of Pain Control for Each Dose Level.', 'timeFrame': '4 years', 'description': 'A reduction in pain, referable to the site of the spine lesion, by \\>=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.'}, {'measure': 'Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.', 'timeFrame': '4 weeks'}, {'measure': 'Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.', 'timeFrame': '4 years'}, {'measure': 'Quality of Life', 'timeFrame': '4 years', 'description': 'As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS)\n\nParticipant can chose on a scale of 0-4 with 0=not at all and 4=very much.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': '(AlvinJ. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate pain control and quality of life in patients with paraspinal metastases, who have receive previous radiation therapy to these lesions, using single dose stereotactic radiotherapy.', 'detailedDescription': 'The goal of the study is to determine the lowest dose of radiation that can be given to effectively control the tumor and provide effective pain relief.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18\n* Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma)\n* Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT\n* Have had prior radiation to area of spine felt to be cause of patient's pain\n* Zubrod performance status of 0-3\n* Life expectancy of ≥ 3 months\n* Signed informed consent prior to registration to study\n* Radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging.\n\nExclusion Criteria:\n\n* Women who are pregnant or nursing\n* Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled'\n* No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention)\n* No initiation of chemotherapy within 15 days of trial entry.\n* No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery.\n* No active systemic infection.\n* No evidence of myelopathy or cauda equina syndrome on clinical evaluation"}, 'identificationModule': {'nctId': 'NCT00802659', 'briefTitle': 'A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Phase I/II Dose Escalation Study to Evaluate Pain Response Using Extracranial Stereotactic Radiosurgery to Treat Paraspinal Metastasis in Patients Who Have Received Prior Spinal Irradiation', 'orgStudyIdInfo': {'id': '07-1149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group -1', 'description': '1000 cGY radiation', 'interventionNames': ['Radiation: Stereotactic radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '1200 cGY radiation', 'interventionNames': ['Radiation: Stereotactic radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '1400 cGY radiation', 'interventionNames': ['Radiation: Stereotactic radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': '1600 cGY radiation', 'interventionNames': ['Radiation: Stereotactic radiotherapy']}], 'interventions': [{'name': 'Stereotactic radiotherapy', 'type': 'RADIATION', 'otherNames': ['Stereotactic Radiosurgery', 'Paraspinal Metastasis', 'Prior Spinal Irradiation'], 'description': "This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.", 'armGroupLabels': ['Group -1', 'Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Jeffrey Bradley, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}