RAdiotherapy for Metastatic Spinal Cord Compression with Increased Radiation DosES (NCT04043156) | Clinical Trial Compass
TerminatedNot Applicable
RAdiotherapy for Metastatic Spinal Cord Compression with Increased Radiation DosES
Stopped: 52 of 65 planned patients were recruited. Since during the study, survival was worse than expected, a new survival score was developed, which was more precise than the tool used for the RAMSES-01 trial. As a consequence, the trial was terminated.
Germany52 participantsStarted 2019-08-08
Plain-language 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. This means that a progression or recurrence of motor deficits (weakness) of the legs following radiotherapy can be avoided more effectively. Furthermore, the high-precision radiotherapy will be compared to the conventional radiotherapy with respect to pain relief, motor function/ability to walk, quality of life, side effects and survival.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Local progression-free survival at 12 months following RT.
Timeframe: For each patient 12 months after the end of RT.