Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-10 @ 11:45 PM
Study NCT ID:
NCT02000518
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emergency Radiotherapy in Metastatic Spinal Cord Compression of Patients With Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-12-03', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neurological outcome', 'timeFrame': '6 weeks after end of radiotherapy', 'description': 'The primary endpoint was neurological outcome, assessed using the ASIA Impairment Scale (AIS)'}], 'secondaryOutcomes': [{'measure': 'local control', 'timeFrame': '6 weeks after end of radiotherapy', 'description': 'according CT scan, local control will be assessed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['emergency radiotherapy', 'MSCC', 'spine', 'neurological outcome'], 'conditions': ['Neurological Outcome', 'Survival From First Diagnosis Metastatic Spinal Cord Compression to Death']}, 'referencesModule': {'references': [{'pmid': '16849752', 'type': 'BACKGROUND', 'citation': 'Rades D, Fehlauer F, Schulte R, Veninga T, Stalpers LJ, Basic H, Bajrovic A, Hoskin PJ, Tribius S, Wildfang I, Rudat V, Engenhart-Cabilic R, Karstens JH, Alberti W, Dunst J, Schild SE. Prognostic factors for local control and survival after radiotherapy of metastatic spinal cord compression. J Clin Oncol. 2006 Jul 20;24(21):3388-93. doi: 10.1200/JCO.2005.05.0542.'}, {'pmid': '2096606', 'type': 'BACKGROUND', 'citation': 'Bach F, Larsen BH, Rohde K, Borgesen SE, Gjerris F, Boge-Rasmussen T, Agerlin N, Rasmusson B, Stjernholm P, Sorensen PS. Metastatic spinal cord compression. Occurrence, symptoms, clinical presentations and prognosis in 398 patients with spinal cord compression. Acta Neurochir (Wien). 1990;107(1-2):37-43. doi: 10.1007/BF01402610.'}, {'pmid': '17851852', 'type': 'BACKGROUND', 'citation': 'Christian E, Adamietz IA, Willich N, Schafer U, Micke O; German Working Group Palliative Radiotherapy; German Society for Radiation Oncology (DEGRO). Radiotherapy in oncological emergencies--final results of a patterns of care study in Germany, Austria and Switzerland. Acta Oncol. 2008;47(1):81-9. doi: 10.1080/02841860701481554.'}, {'pmid': '24373638', 'type': 'DERIVED', 'citation': 'Rief H, Heinhold RC, Petersen LC, Rieken S, Bruckner T, Moghaddam-Alvandi A, Debus J, Sterzing F. Neurological outcome after emergency radiotherapy in MSCC of patients with non-small cell lung cancer--a prospective trial. Radiat Oncol. 2013 Dec 28;8:297. doi: 10.1186/1748-717X-8-297.'}]}, 'descriptionModule': {'briefSummary': 'Acute neurological deficit in metastatic spinal cord compression is an emergency condition in radiation oncology. Despite some reports about the high efficacy of radiation treatment for oncological emergencies, a standard of care is not well defined, especially the time interval of immediate RT after deficit, and neurological outcome with respect to poor survival in non-small cell lung cancer patients. The objective of this trial is to investigate neurological outcome after emergency radiotherapy in metastatic spinal cord compression of non-small cell lung cancer patients with acute neurological deficit.', 'detailedDescription': 'Subjects and recruitment 15 consecutive patients with histologically confirmed non-small cell lung cancer and bone metastases of the thoracic or lumbar segments of the vertebral column will be screened for this trial in the Radiooncology Department of the Heidelberg University Clinic. Inclusion criteria are an age of 18 to 80 years, acute neurological symptom caused by metastatic spinal cord compression, no radiotherapy in this spinal area before, and written consent to participate.\n\nDesign and procedures This is a prospective, controlled, explorative trial to investigate the neurological outcome after emergency radiotherapy in metastatic spinal cord compression of non-small cell lung cancer patients with acute neurological deficit. RT start within 12 hours after onset of neurological symptoms. The target parameters will be measured at the start of radiotherapy (t0), and six weeks after radiotherapy (RT) (t1). The target parameters comprise the documentation and completion of the ASIA Impairment Scale (AIS), and the recording of patient-specific data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'histologically confirmed non-small cell lung cancer and bone metastases of the thoracic or lumbar segments of the vertebral column', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria are an age of 18 to 80 years, acute neurological symptom caused by metastatic spinal cord compression, no RT in this spinal area before, and written consent to participate.\n\nExclusion Criteria:\n\n* neurological symptom more than 12 hours before'}, 'identificationModule': {'nctId': 'NCT02000518', 'acronym': 'CK-INF', 'briefTitle': 'Emergency Radiotherapy in Metastatic Spinal Cord Compression of Patients With Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Phase 1 Study of Neurological Outcome After Emergency Radiotherapy in Metastatic Spinal Cord Compression', 'orgStudyIdInfo': {'id': 'S-514/2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'external beam radiotherapy', 'description': 'emergency radiotherapy within 12 hours after neurological deficit due to MSCC', 'interventionNames': ['Radiation: external beam radiotherapy']}], 'interventions': [{'name': 'external beam radiotherapy', 'type': 'RADIATION', 'armGroupLabels': ['external beam radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University hospital of Heidelberg, Departement radiation oncology', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurological outcome after emergency radiotherapy in MSCC of patients with non-small cell lung cancer', 'investigatorFullName': 'Alexandra Jensen', 'investigatorAffiliation': 'Heidelberg University'}}}}