Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-28 @ 2:26 AM
Study NCT ID:
NCT01527292
Status:
TERMINATED
Last Update Posted:
2019-02-05
First Post:
2012-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'sywoo001@exchange.louisville.edu', 'phone': '502-561-2700', 'title': 'Dr. Shiao Woo', 'organization': 'University of Louisville, James Graham Brown Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only\n\nStereotactic Radiation Therapy: SRT only', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure\n\nSRT with Vertebral Augmentation Procedure: SRT with VAP', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Numerical Rating Pain Scale (NRPS) Change in Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only\n\nStereotactic Radiation Therapy: SRT only'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure\n\nSRT with Vertebral Augmentation Procedure: SRT with VAP'}], 'timeFrame': 'For 6 months post treatment', 'description': 'To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to low enrollment and early termination of study'}, {'type': 'SECONDARY', 'title': 'Reduction of Pain Estimate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only\n\nStereotactic Radiation Therapy: SRT only'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure\n\nSRT with Vertebral Augmentation Procedure: SRT with VAP'}], 'timeFrame': 'For 1 year post treatment', 'description': 'To estimate the relative quantitative reduction of pain from baseline in patients in each arm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to low enrollment and early termination of study'}, {'type': 'SECONDARY', 'title': 'Quality of Life Estimate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only\n\nStereotactic Radiation Therapy: SRT only'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure\n\nSRT with Vertebral Augmentation Procedure: SRT with VAP'}], 'timeFrame': 'For 1 year post treatment', 'description': 'To estimate the quality of life using the Oswestry Disability Questionnaire', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to low enrollment and early termination of study'}, {'type': 'SECONDARY', 'title': 'Feasibility Rate Estimation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only\n\nStereotactic Radiation Therapy: SRT only'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure\n\nSRT with Vertebral Augmentation Procedure: SRT with VAP'}], 'timeFrame': 'For 1 year post treatment', 'description': 'To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to low enrollment and early termination of study'}, {'type': 'SECONDARY', 'title': 'Toxicity Rate Estimation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only\n\nStereotactic Radiation Therapy: SRT only'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure\n\nSRT with Vertebral Augmentation Procedure: SRT with VAP'}], 'timeFrame': 'For 1 year post treatment', 'description': 'To estimate the toxicities of the treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to low enrollment and early termination of study'}, {'type': 'SECONDARY', 'title': 'Vertebra Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only\n\nStereotactic Radiation Therapy: SRT only'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure\n\nSRT with Vertebral Augmentation Procedure: SRT with VAP'}], 'timeFrame': 'For 1 year post treatment', 'description': 'To measure the dimensions of the treated vertebra(e) at 1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to low enrollment and early termination of study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only\n\nStereotactic Radiation Therapy: SRT only'}, {'id': 'FG001', 'title': 'Treatment Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure\n\nSRT with Vertebral Augmentation Procedure: SRT with VAP'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only\n\nStereotactic Radiation Therapy: SRT only'}, {'id': 'BG001', 'title': 'Treatment Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure\n\nSRT with Vertebral Augmentation Procedure: SRT with VAP'}, {'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': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG001', 'lowerLimit': '56', 'upperLimit': '64'}, {'value': '61', 'groupId': 'BG002', 'lowerLimit': '56', 'upperLimit': '64'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Trial did not meet enrollment goal. Investigator did not analyze data due to low enrollment and early termination of trial'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Unable to enroll', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2012-02-02', 'resultsFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2012-02-06', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-14', 'studyFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Rating Pain Scale (NRPS) Change in Patients', 'timeFrame': 'For 6 months post treatment', 'description': 'To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score'}], 'secondaryOutcomes': [{'measure': 'Reduction of Pain Estimate', 'timeFrame': 'For 1 year post treatment', 'description': 'To estimate the relative quantitative reduction of pain from baseline in patients in each arm.'}, {'measure': 'Quality of Life Estimate', 'timeFrame': 'For 1 year post treatment', 'description': 'To estimate the quality of life using the Oswestry Disability Questionnaire'}, {'measure': 'Feasibility Rate Estimation', 'timeFrame': 'For 1 year post treatment', 'description': 'To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment).'}, {'measure': 'Toxicity Rate Estimation', 'timeFrame': 'For 1 year post treatment', 'description': 'To estimate the toxicities of the treatment'}, {'measure': 'Vertebra Measurement', 'timeFrame': 'For 1 year post treatment', 'description': 'To measure the dimensions of the treated vertebra(e) at 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vertebral Metastasis', 'pain control', 'VAP', 'SRT+VAP'], 'conditions': ['Vertebral Metastasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months post-treatment.', 'detailedDescription': 'Eligible Vertebral Metastatic Lesion/s-\\> randomized-\\> SRT versus SRT+ VAP Stereotactic Radiation Therapy(SRT): 16 Gy X 1 Evaluation: prior to treatment; 1 month, 2-4 months, 5-6 months and 1 year post-treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. ECOG performance status 0-1.\n3. Known histologically proven malignancy.\n4. Localized osteolytic spine metastases from T7 to L5 demonstrated by MRI, CT, PET or bone scan: a solitary spine metastasis; two separate spine levels; or up to 3 separate sites (each site may have a maximal involvement of 2 contiguous vertebral bodies with or without a paraspinal mass of no more than 5 cm).\n5. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.\n6. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.\n7. Numerical Rating Pain Scale (NRPS) and movement-related pain score(MRPS) within two (2) weeks prior to registration.\n8. The patient must have a score of ≥ 5 for at least one of the planned sites for SRT.\n9. Patients must provide study specific informed consent prior to study entry.\n10. Required Pre-treatment Evaluations: baseline Numerical Rating Pain Scale (NRPS), movement-related pain score, dose and frequency of all pain medications; QOL Measure using the Oswestry Disability Questionnaire, and EuroQOL(EQ-5D).\n\nExclusion Criteria:\n\n1. Non-ambulatory patients.\n2. Frank spinal cord compression or epidural compression within 3 mm of the spinal cord.\n3. Osteoblastic vertebral metastasis.\n4. Prior radiation to the index spine.\n5. Patients with rapid neurologic decline.'}, 'identificationModule': {'nctId': 'NCT01527292', 'briefTitle': 'Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis', 'orgStudyIdInfo': {'id': 'BCC-RAD-11-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only', 'interventionNames': ['Radiation: Stereotactic Radiation Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'SRT with Vertebral Augmentation Procedure Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure', 'interventionNames': ['Radiation: SRT with Vertebral Augmentation Procedure']}], 'interventions': [{'name': 'Stereotactic Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Stereotactic Radiosurgery'], 'description': 'SRT only', 'armGroupLabels': ['Control Group']}, {'name': 'SRT with Vertebral Augmentation Procedure', 'type': 'RADIATION', 'otherNames': ['Stereotactic Radiosurgery with VAP'], 'description': 'SRT with VAP', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'James Graham Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Shiao Y Woo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'James Graham Brown Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'James Graham Brown Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair-Radiation Oncology', 'investigatorFullName': 'Shiao Yuo Woo', 'investigatorAffiliation': 'University of Louisville'}}}}