bone metastases metastatic bone disease
Conditions
Interventions
Patients will undergo MRI-based, cone beam CT-guided SBRT and will receive a
single dose of 18 Gray (Gy) on the visible metastasis, and 8 Gy on the bony
compartment containing the metastasis (e.g. t
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Radiographic evidence of bone metastases; Per spinal lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below; No more than 2 painful lesions needing treatment; Histologic proof of malignancy; No compression of spinal cord; No or mild neurological signs (i.e. radiculopathy, dermatomal sensory change, and muscle strength of involved extremity is Medical Research Counsil (MRC) 4/5); Medically inoperable or patient refused surgery; Karnofsky performance score (KPS) * 50; Numeric rating scale (NRS) * 3; Age * 18 years; Written informed consent; Filling out PRESENT-questionnaires.
Exclusion criteria
Exclusion criteria: General exclusion criteria: Radiosensitive histology such as multiple myeloma, lymphoma, small cell and germ cell; MRI cannot be completed for any reason (in according with the MRI protocol of the Department of Radiology); Impossible to delineate metastasis and organs at risk (OAR) due to artefacts on CT or MRI from previous surgical stabilisation; Unable to undergo SBRT treatment, according to treating doctor*s opinion; Severe, worsening or progressive neurological deficit; Unstable bone requiring surgical stabilization; Patient with 10 cm; Extension of the tumour to the skin. ;Spinal metastases specific exclusion criteria: Lesion in C1 and C2; Epidural disease.;Specific exclusion criteria for bone metastases in the extremities: Fixation material in target volume; Impending fracture (if surgery or stabilisation is an option).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is pain control at three months after radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the occurence of vertebral compression fracture (VCF) and radiation induced myelopathy in spinal metastases, evaluation of local tumour control and toxicity after SBRT, measurement of duration and rapidity of pain relief, evaluation of quality of life, and evaluation of progression free and overall survival. | — |
Countries
Netherlands
Outcome results
None listed