Study of Image-Guided SBRT for Vertebral Metastases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Image-Guided Single Fraction SBRT With VMAT-FFF Technique for Vertebral Metastases

Conditions
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Vertebral Metastases

Intervention / Treatment
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* Radiation: Single dose SBRT and VMAT technique


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vertebral metastases<br>Selected patients with spine metastases are treated with ablative single dose SBRT and VMAT technique in various solid tumors . | Radiation: Single dose SBRT and VMAT technique<br>* One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of single fraction SBRT on spine metastases using CTCAE v.4 |  | 1 year | 
| Local control of the treated lesions using Kaplan-Meyer statistical curves |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |