Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-01 @ 1:47 AM
Study NCT ID:
NCT00853528
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2009-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Radiosurgery in Treating Patients With Spinal Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056324', 'term': 'Diffusion Tensor Imaging'}], 'ancestors': [{'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a Phase I study with 2 parallel groups of dose escalation using a 3 +3 design to determine the maximum tolerated dose of the radiation with the FDA approved device. There are three dose cohorts in each group, thus 6 arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2009-02-27', 'studyFirstSubmitQcDate': '2009-02-27', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose - single fraction', 'timeFrame': '6 weeks', 'description': 'Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery'}, {'measure': 'Maximum tolerated dose - hypofraction', 'timeFrame': '6 weeks', 'description': 'Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery'}], 'secondaryOutcomes': [{'measure': 'Assessment of pain', 'timeFrame': 'baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment', 'description': 'Pain as measured by the Brief Pain Inventory and Roland scale'}, {'measure': 'Spinal cord response', 'timeFrame': 'baseline and then at 6 weeks and 6 months after completion of treatment', 'description': 'Spinal cord response as measured by functional MRI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['spinal cord metastases'], 'conditions': ['Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.', 'detailedDescription': 'OBJECTIVES:\n\n* To implement CyberKnife® technology for improving palliation in patients with spinal metastases.\n* To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in these patients.\n* To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after treatment with Cyberknife® radiosurgery.\n\nOUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.\n\nPatients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.\n\nAfter completion of study treatment, patients are followed periodically for up to 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic spinal tumor\n\n * Localized spinal metastasis, defined as one of the following:\n\n * Solitary spinal metastasis\n * Two contiguous spinal levels\n\n * No more than 2 adjacent spinal levels involved by a single tumor\n * Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12)\n * Tumor size ≤ 5 cm\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 60-100%\n* Life expectancy ≥ 6 months\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Must be ambulatory\n\nExclusion Criteria:\n\n* Not pregnant or nursing\n* No spinal instability\n* No rapid neurological decline\n* No bony retropulsions causing neurological abnormalities\n* No total paraplegia for \\> 48 hours\n* No psychological issues that would preclude completion of study treatment\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields\n* No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance\n* No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)'}, 'identificationModule': {'nctId': 'NCT00853528', 'briefTitle': 'Stereotactic Radiosurgery in Treating Patients With Spinal Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine', 'orgStudyIdInfo': {'id': 'H-26577'}, 'secondaryIdInfos': [{'id': 'W81XWH-07-1-0342', 'type': 'OTHER_GRANT', 'domain': 'Dept of Defense'}, {'id': 'CDR0000635267', 'type': 'OTHER', 'domain': 'BUMC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-fraction radiosurgery; 16 Gray', 'description': 'Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging', 'interventionNames': ['Other: questionnaire administration', 'Procedure: diffusion tensor imaging', 'Procedure: functional magnetic resonance imaging', 'Radiation: single-fraction SRS']}, {'type': 'EXPERIMENTAL', 'label': 'Hypo-fractionated radiosurgery; 21 Gray', 'description': 'Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray', 'interventionNames': ['Other: questionnaire administration', 'Procedure: diffusion tensor imaging', 'Procedure: functional magnetic resonance imaging', 'Radiation: hypo-fractionated SRS']}, {'type': 'EXPERIMENTAL', 'label': 'Single-fraction radiosurgery; 18 Gray', 'description': 'Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging', 'interventionNames': ['Other: questionnaire administration', 'Procedure: diffusion tensor imaging', 'Procedure: functional magnetic resonance imaging', 'Radiation: single-fraction SRS']}, {'type': 'EXPERIMENTAL', 'label': 'Single-fraction radiosurgery; 20 Gray', 'description': 'Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging', 'interventionNames': ['Other: questionnaire administration', 'Procedure: diffusion tensor imaging', 'Procedure: functional magnetic resonance imaging', 'Radiation: single-fraction SRS']}, {'type': 'EXPERIMENTAL', 'label': 'Hypo-fractionated radiosurgery; 24 Gray', 'description': 'Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray', 'interventionNames': ['Other: questionnaire administration', 'Procedure: diffusion tensor imaging', 'Procedure: functional magnetic resonance imaging', 'Radiation: hypo-fractionated SRS']}, {'type': 'EXPERIMENTAL', 'label': 'Hypo-fractionated radiosurgery; 27 Gray', 'description': 'Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray', 'interventionNames': ['Other: questionnaire administration', 'Procedure: diffusion tensor imaging', 'Procedure: functional magnetic resonance imaging', 'Radiation: hypo-fractionated SRS']}], 'interventions': [{'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment', 'armGroupLabels': ['Hypo-fractionated radiosurgery; 21 Gray', 'Hypo-fractionated radiosurgery; 24 Gray', 'Hypo-fractionated radiosurgery; 27 Gray', 'Single-fraction radiosurgery; 16 Gray', 'Single-fraction radiosurgery; 18 Gray', 'Single-fraction radiosurgery; 20 Gray']}, {'name': 'diffusion tensor imaging', 'type': 'PROCEDURE', 'description': 'prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy', 'armGroupLabels': ['Hypo-fractionated radiosurgery; 21 Gray', 'Hypo-fractionated radiosurgery; 24 Gray', 'Hypo-fractionated radiosurgery; 27 Gray', 'Single-fraction radiosurgery; 16 Gray', 'Single-fraction radiosurgery; 18 Gray', 'Single-fraction radiosurgery; 20 Gray']}, {'name': 'functional magnetic resonance imaging', 'type': 'PROCEDURE', 'description': 'prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter', 'armGroupLabels': ['Hypo-fractionated radiosurgery; 21 Gray', 'Hypo-fractionated radiosurgery; 24 Gray', 'Hypo-fractionated radiosurgery; 27 Gray', 'Single-fraction radiosurgery; 16 Gray', 'Single-fraction radiosurgery; 18 Gray', 'Single-fraction radiosurgery; 20 Gray']}, {'name': 'hypo-fractionated SRS', 'type': 'RADIATION', 'description': 'two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy', 'armGroupLabels': ['Hypo-fractionated radiosurgery; 21 Gray', 'Hypo-fractionated radiosurgery; 24 Gray', 'Hypo-fractionated radiosurgery; 27 Gray']}, {'name': 'single-fraction SRS', 'type': 'RADIATION', 'description': 'two to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy', 'armGroupLabels': ['Single-fraction radiosurgery; 16 Gray', 'Single-fraction radiosurgery; 18 Gray', 'Single-fraction radiosurgery; 20 Gray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Cancer Research Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Minh-Tam Truong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BMC Attending Physician', 'investigatorFullName': 'Minh Tam Truong', 'investigatorAffiliation': 'Boston Medical Center'}}}}