Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT01826058
Status:
UNKNOWN
Last Update Posted:
2014-12-02
First Post:
2013-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013117', 'term': 'Spinal Cord Compression'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'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'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-27', 'studyFirstSubmitDate': '2013-04-03', 'studyFirstSubmitQcDate': '2013-04-05', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurologic response', 'timeFrame': '1 month', 'description': '* Neurologic response is defined as maintaining grade 4 or more motor power after completing SBRT or as an increase of motor power by at least 1 grade from the baseline motor power.\n* There should no decrease of motor power after completing SBRT.\n* The motor weakness is graded from 0 to 5 by Medical Research Council (MRC) scale.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stereotactic body radiation therapy', 'Radiosurgery'], 'conditions': ['Spinal Cord Compression']}, 'descriptionModule': {'briefSummary': 'Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that requires to be treated promptly. Although direct decompressive surgery is the most effective treatment, surgery is only used in selected patients because most patients have a poor overall condition and short life expectancy. Radiation therapy (RT), therefore, is the most commonly used for patients with MESCC, but conventional RT alone can achieve modest neurologic outcomes.\n\nThe hypothesis to use stereotactic body radiation therapy (SBRT) for MESCC is that the rapid decompression of epidural mass, durable local control and subsequently improved neurologic outcomes compared to conventional RT are expected when MESCC is treated with SBRT.', 'detailedDescription': 'The definition of metastatic epidural spinal cord compression (MESCC)\n\n* MESCC is defined as both an evidence of cord compression by radiologic evaluation and a manifestation of clinical feature at the level of cord compression.\n* A cord compression by radiologic evaluation is defined as \\< 3mm gap between epidural mass and true spinal cord or indentation of thecal sac at the level of clinical feature by MRI.\n* Clinical features include any or all of the followings: pain (local or radicular) or motor weakness or sensory change or incontinence.\n\nSimulation -A Computed tomography (CT) scan will be acquired with the use of intravenous contrast and planning MRI will be also performed on the same day of simulation.\n\nSpine SBRT\n\n\\- One to four sessions of SBRT will be performed.\n\nFollow-up\n\n* Patients need to be assessed at 1 week, 1 month and 3 months after the completion of SBRT and will be followed up at 3 month intervals thereafter.\n* Pain score, neurologic examination, adverse events and simple X-ray of involved spine should be evaluated at every follow-up visit.\n* MRI of involved spine will be performed at 3 months after the completion of SBRT.\n\nUp to 43 patients will be enrolled in this study in Samsung Medical Center, Seoul National University Hospital, and Gachon University Gil Medical Center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MESCC is present.\n* Localized spine metastases (C1 to L5 level); Maximum 3 separate sites and maximum 2 contiguous vertebral bodies\n* Performance state before the occurrence of neurologic symptoms : Eastern Cooperative Oncology Group 0-2\n* Age ≥20\n* MRI within 2 weeks is mandatory\n* Paraspinal mass \\< 5cm in maximum dimension\n* Inoperable patients - refused or medically unfit for decompression surgery\n* life expectancy \\> 3 months\n\nExclusion Criteria:\n\n* Retropulsed bony fragment causing cord compression\n* Paraplegia ≥ 48 hours\n* Histology preferred to perform the chemotherapy as the first option (e.g. lymphoma, myeloma)'}, 'identificationModule': {'nctId': 'NCT01826058', 'briefTitle': 'Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord: Prospective Phase II Study', 'orgStudyIdInfo': {'id': 'KROG 1316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stereotactic body radiation therapy', 'description': "SBRT in one to four fractions\n\nIrradiated total RT dose to gross tumor volume (GTV) according to fraction size\n\n* 1 fx: 16 to 24 Gy\n* 2 fx's: 20 to 26 Gy\n* 3 fx's: 21 to 30 Gy\n* 4 fx's: 24 to 36 Gy", 'interventionNames': ['Radiation: Stereotactic body radiation therapy']}], 'interventions': [{'name': 'Stereotactic body radiation therapy', 'type': 'RADIATION', 'otherNames': ['Radiosurgery', 'SRS', 'Radiation', 'Radiotherapy', 'Metastatic Epidural Spinal Cord Compression', 'MESCC'], 'armGroupLabels': ['Stereotactic body radiation therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Doo Ho Choi, MD.PhD.', 'role': 'CONTACT', 'email': 'doho.choi@samsung.com', 'phone': '82-2-3410-2436'}, {'name': 'Dongryul Oh, MD', 'role': 'CONTACT', 'email': 'dongryuloh@gmail.com', 'phone': '82-2-3410-2615'}, {'name': 'Doo Ho Choi, MD.PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Doo Ho Choi, MD. PhD.', 'role': 'CONTACT', 'email': 'doho.choi@samsung.com', 'phone': '82-2-3410-2436'}, {'name': 'Donryul Oh, MD', 'role': 'CONTACT', 'email': 'dongryuloh@gmail.com', 'phone': '82-2-3410-2613'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine', 'investigatorFullName': 'Doo Ho Choi', 'investigatorAffiliation': 'Samsung Medical Center'}}}}