Status:
TERMINATED
RAdiotherapy for Metastatic Spinal Cord Compression with Increased Radiation DosES
Lead Sponsor:
University Hospital Schleswig-Holstein
Conditions:
Spinal Cord Compression Due to Metastasis to Spine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical study aims to investigate whether high-precision radiotherapy, as supposed, leads to a better control of the irradiated spinal cord metastases when compared to conventional radiotherapy....
Detailed Description
The aim of this single-arm study is to show that high-precision radiotherapy (RT) with 18x2.33 Gy in 3.5 weeks results in significantly better local progression free survival (LPFS) of metastatic spin...
Eligibility Criteria
Inclusion
- Motor deficits of the lower extremities resulting from MSCC, which have persisted for no longer than 30 days
- Confirmation of diagnosis by MR-imaging (computed tomography \[CT\] allowed)
- Age 18 years or older
- Written informed consent
- Favorable survival prognosis (defined as 36-45 points on the survival score)
- Capacity of the patient to contract
Exclusion
- Previous RT or surgery of the spinal areas affected by MSCC
- Symptomatic brain tumor or symptomatic brain metastases
- Metastases of the cervical spine only
- Other severe neurological disorders
- Pregnancy, Lactation
- Clear indication for spinal surgery
Key Trial Info
Start Date :
August 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04043156
Start Date
August 8 2019
End Date
January 5 2023
Last Update
January 15 2025
Active Locations (1)
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1
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Ratzeburger Allee 160, 23562 Lübeck, Germany
Lübeck, Germany, 23562