- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02000518
Emergency Radiotherapy in Metastatic Spinal Cord Compression of Patients With Non-small Cell Lung Cancer (CK-INF)
Phase 1 Study of Neurological Outcome After Emergency Radiotherapy in Metastatic Spinal Cord Compression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Design 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Heidelberg, Germany, 69120
- University hospital of Heidelberg, Departement radiation oncology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- neurological symptom more than 12 hours before
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
external beam radiotherapy
emergency radiotherapy within 12 hours after neurological deficit due to MSCC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
neurological outcome
Time Frame: 6 weeks after end of radiotherapy
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The primary endpoint was neurological outcome, assessed using the ASIA Impairment Scale (AIS)
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6 weeks after end of radiotherapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
local control
Time Frame: 6 weeks after end of radiotherapy
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according CT scan, local control will be assessed
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6 weeks after end of radiotherapy
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-514/2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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