N/A
N=203
Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression
Metastatic Epidural Spinal Cord Compression
Bottom Line
View on ClinicalTrials.gov: NCT02189473 ↗Enrolled (actual)
203
Serious AEs
9.4%
Results posted
Feb 2020
Primary outcome: Primary: Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy — 68; 69 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Prof. Dirk Rades, MD
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy |
68; 69 | — |
| SECONDARY Number of Participants Who Were Able to Walk at 1 Month Following Radiotherapy |
56; 57 | — |
| SECONDARY Number of Participants Who Were Alive at 6 Months Following Radiotherapy Without Deterioration of Motor Function During (or Directly Following) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy |
75.2; 81.8 | — |
| SECONDARY Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline |
43; 47 | — |
| SECONDARY Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline |
36; 40 | — |
| SECONDARY Number of Participants Who Were Alive at 6 Months Following Radiotherapy |
42.3; 37.8 | — |
| SECONDARY Number of Participants Showing Improvement of Motor Deficits at 1 Month Following Radiotherapy |
30; 34 | — |
| SECONDARY Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity |
11; 15; 90; 87 | — |
Summary
The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression.
Eligibility Criteria
Inclusion Criteria
- Motor deficits of the lower extremities resulting from metastatic epidural spinal cord compression, which have persisted for no longer than 30 days
- Confirmation of diagnosis by magnetic resonance imaging (spinal computed tomography allowed)
- Relatively poor survival prognosis (defined as ≤35 points on the survival score published in Cancer 2008)
- Written informed consent
Exclusion Criteria
- Prior radiotherapy or surgery of the spinal areas affected by MESCC
- History of symptomatic brain tumor or symptomatic brain metastases
- Metastases of the cervical spine only
- Other severe neurological disorders
- Pregnancy, Lactation
- Indication for decompressive surgery + stabilization of the affected spinal areas
Data sourced from ClinicalTrials.gov (NCT02189473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.