N/A
N=44
High-precision Radiotherapy of Motor Deficits Due to Metastatic Spinal Cord Compression
Spinal Cord Compression Due to Metastasis to Spine
Bottom Line
View on ClinicalTrials.gov: NCT03070431 ↗Enrolled (actual)
44
Serious AEs
12.5%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants Who Were Alive at 6 Months After Radiotherapy Without Deterioration of Motor Function During (or Directly After) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy — 95.0 percentage of participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-precision RT 5x5 Gy in 1 week (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital Schleswig-Holstein
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were Alive at 6 Months After Radiotherapy Without Deterioration of Motor Function During (or Directly After) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy |
95.0 | <0.05 sig |
| SECONDARY Number of Participants Showing Improvement of Motor Deficits Following Radiotherapy (Best Response) |
24; 16 | — |
| SECONDARY Number of Participants Showing Improvement of Sensory Function Following Radiotherapy (Best Response) |
8; 8 | — |
| SECONDARY Number of Participants Showing Improvement of Sphincter Dysfunction Following Radiotherapy (Best Response) |
2; 2; 2 | — |
| SECONDARY Number of Participants Who Were Alive at 3 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 |
95 | — |
| SECONDARY Number of Participants Who Were Alive at 6 Months Following Radiotherapy |
45.0 | — |
| SECONDARY Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline |
13; 8 | — |
| SECONDARY Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline |
13; 11 | — |
| SECONDARY Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity |
4; 36; 1; 39 | — |
| SECONDARY Number of Participants Who Were Able to Walk Following Radiotherapy |
33; 7 | — |
Summary
The major goal of this clinical study is to investigate to which extent high-precision radiotherapy (RT) with modern techniques can prevent progression or recurrence of motor deficits (weakness) of the legs following RT. In addition, it will be evaluated to which extent RT can lead to improvement of motor function, ambulatory status, sensory function and sphincter dysfunction, to pain relief and to improvement in quality of life, side effects and overall survival. For this purpose 44 patients who will receive modern high-precision RT treatment for the metastases on their vertebral bodies will be included into this phase 2 study. The results of the high-precision RT with a treatment of 5x5 Gray (Gy) in 1 week will be compared to data of a historical control group. The data set of the historical control group consists of more than 500 patients who received conventional RT with 5x4 Gy. The data collected in 1 week treatment will be compared. It is intended to show superiority regarding the local progression-free survival (LPFS) for the high-precision RT when compared with the conventional RT.
Eligibility Criteria
Inclusion Criteria
- Motor deficits of the lower extremities resulting from MSCC, which have persisted for no longer than 30 days
- Confirmation of diagnosis by magnetic resonance (MR) imaging (computed tomography (CT) allowed)
- Age 18 years or older
- Written informed consent
- Capacity of the patient to contract
Exclusion Criteria
- Previous RT or surgery of the spinal areas affected MSCC
- Symptomatic brain tumor or symptomatic brain metastases
- Metastases of the cervical spine only
- Other severe neurological disorders
- Pregnancy, lactation period
- Indication for decompressive surgery of affected spinal areas
Data sourced from ClinicalTrials.gov (NCT03070431). 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.