Vertebral Metastases
Conditions
Brief summary
Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid tumors, investigators have designed this study to assess feasibility of SBRT in selected patients with spine metastases.
Detailed description
This is a prospective, phase 2 study. The main objectives are to assess acute and late side effects of single fraction SBRT for selected patients with vertebral metastases and to study the local control of disease in treated sites. The schedule will be 1 fraction of 18 Gy delivered in one day with Volumetric Modulated Arc Therapy (VMAT) and Flattening filter-free (FFF) beams.
Interventions
RADIATIONSingle dose SBRT and VMAT technique
One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams.
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18years. * WHO performance status ≤ 2 (ECOG - KPS). * Histologically-proven of primary cancer disease. * Metastatic disease in the spine, from C1 to Sacrum. A maximum number of 5 sites. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. * Epidural compression is eligible when there is at least 3 mm gap between the spinal cord and the edge of the epidural lesion, unless patient underwent decompression surgery. * A paraspinal mass ≤ 5 cm. * Minimal residual tumor after surgery * Metastases in other district of the body are allowed. * Informed consent.
Exclusion criteria
* \> 50% loss of vertebral body height. * Prior radiation to the interested spine. * Patients for whom an MRI of the spine is medically contraindicated. * Patients allergic to contrast used in MRIs or CT scans or who cannot be premedicated for the use of contrast.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control of the treated lesions using Kaplan-Meyer statistical curves | 1 year |
| Toxicity of single fraction SBRT on spine metastases using CTCAE v.4 | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Pain control at treated sites after RT using CTCAE v.4 | 3 months |
| Local control of the metastatic disease using Kaplan-Meyer statistical curves | 3 months |
| Overall survival of treated patients using Kaplan-Meyer statistical curves | 1 year |
| Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4 | 3 months |
Countries
Italy
Outcome results
None listed