Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-28 @ 11:45 AM
Study NCT ID:
NCT01654068
Status:
TERMINATED
Last Update Posted:
2019-04-19
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008968', 'term': 'Molecular Conformation'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rcmcga2@email.uky.edu', 'phone': '859-323-6486', 'title': 'Ronal McGarry', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '0-209 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Radiation Therapy to Local Spine Metastasis', 'description': 'Conformal High Dose Intensity Modulated Radiation Therapy\n\nConformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 11, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Bilateral Leg Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Vertebral Compression Fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Any Skeletal Related Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy to Local Spine Metastasis', 'description': 'Conformal High Dose Intensity Modulated Radiation Therapy\n\nConformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 24 months', 'description': 'Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival).', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acute Radiation Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy to Local Spine Metastasis', 'description': 'Conformal High Dose Intensity Modulated Radiation Therapy\n\nConformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy)', 'unitOfMeasure': 'event (possible acute side effect)', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Late Radiation Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy to Local Spine Metastasis', 'description': 'Conformal High Dose Intensity Modulated Radiation Therapy\n\nConformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'The number of late side effects of radiation therapy will be documented (\\> 90 days after the start of radiation therapy)', 'unitOfMeasure': 'events (possible late side effects)', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiation Therapy to Local Spine Metastasis', 'description': 'Conformal High Dose Intensity Modulated Radiation Therapy\n\nConformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiation Therapy to Local Spine Metastasis', 'description': 'Conformal High Dose Intensity Modulated Radiation Therapy\n\nConformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Never Smoker', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Former Smoker', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Current Smoker', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Site of Metastasis', 'classes': [{'title': 'Thoracic Spine', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Lumbar Spine', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-06-27', 'size': 216171, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-19T10:18', 'hasProtocol': True}, {'date': '2013-06-24', 'size': 478637, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-03-19T10:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'low participant accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2016-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2012-07-17', 'resultsFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2012-07-30', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-16', 'studyFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Any Skeletal Related Event', 'timeFrame': 'up to 24 months', 'description': 'Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival).'}], 'secondaryOutcomes': [{'measure': 'Acute Radiation Toxicity', 'timeFrame': '90 days', 'description': 'The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy)'}, {'measure': 'Late Radiation Toxicity', 'timeFrame': '2 years', 'description': 'The number of late side effects of radiation therapy will be documented (\\> 90 days after the start of radiation therapy)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Female Breast Cancer', 'Kidney Cancer', 'Lung Cancer', 'Prostate Cancer', 'Vertebral metastasis'], 'conditions': ['Vertebral Metastasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Conformal High Dose Intensity Modulated Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal column. This study involves patients who have been diagnosed with metastatic cancer to the thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the area of concern. The goal is to prove that this is not only a safe form of treatment, but that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer coming back in the area that the investigators treat which may reduce the risk of developing symptoms like pain in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histological confirmation of malignancy (non-small cell lung cancer, breast cancer (hormone refractory), prostate cancer (hormone refractory), lymphoma, renal cell carcinoma, myeloma by either biopsy or cytology of the primary or metastatic lesion.\n* Patients must have radiological documentation of metastatic disease to the thoracic or lumbar spine including both positron emitted tomography (PET) or nuclear medicine bone scan (NMBS) and Magnetic Resonance Imaging (MRI) within 4 weeks prior to study entry.\n* Patients with one to three spinal metastases to the thoracic or lumbar spine will be included.\n* Spinal metastatic lesions should be limited to one vertebral body level or ≤ 6cm in greatest dimension.\n* Tumors should not directly abut the spinal cord, and have at least 5mm separation from the spinal cord. For patients with tumors closer than 5mm, inclusion is permissible at the discretion of the treating radiation oncologist such that dosimetric review demonstrates that the total dose to spinal cord is within tolerable range of \\<10Gy to 10% partial volume or max point dose 18 Gy.\n* Patients must be able to fit into either the Elekta Stereotactic Body Frame or the Elekta Stereotactic BodyFix immobilization device.\n* Must be ≥ 18 years of age.\n* ECOG status 0-2.\n* Women of childbearing potential and male participants must use an effective contraception method. (Until at least 60 days following treatment.)\n* Negative urine pregnancy test within at least one week before starting treatment in women of child-bearing age.\n* Patients must sign a study-specific informed consent form.\n\nExclusion Criteria:\n\n* Patients with evidence of spinal instability OR neurologic deficit resulting from bony compression of neurologic structures.\n* Patients with other systemic illness, or have not recovered adequately from their primary treatment or who have evidence of progression of their current cancer prior to therapy that, in the investigator's opinion, would preclude their inclusion.\n* Patient may not receive concomitant cytotoxic anti-neoplastic therapy during treatment. Patients may be allowed to use hormonal suppression therapy or bisphosphonates for hypercalcemia.\n* Pregnant or lactating women.\n* Any patient with symptoms of pain, compression fracture, neurologic deficit will not be included.\n* Patients previously treated with radiation therapy to the thoracic or lumbar spinal levels of involved disease will not be included."}, 'identificationModule': {'nctId': 'NCT01654068', 'briefTitle': 'Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine', 'orgStudyIdInfo': {'id': 'MCC-09-RAD-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiation Therapy to Local Spine Metastasis', 'description': 'Conformal High Dose Intensity Modulated Radiation Therapy to a single asymptomatic local spine metastasis.', 'interventionNames': ['Radiation: Conformal High Dose Intensity Modulated Radiation Therapy']}], 'interventions': [{'name': 'Conformal High Dose Intensity Modulated Radiation Therapy', 'type': 'RADIATION', 'description': 'Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons', 'armGroupLabels': ['Radiation Therapy to Local Spine Metastasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Ronald McGarry, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ronald McGarry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Radiation Medicine', 'investigatorFullName': 'Ronald McGarry', 'investigatorAffiliation': 'University of Kentucky'}}}}