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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vertebral metastases | Selected patients with spine metastases are treated with ablative single dose SBRT and VMAT technique in various solid tumors . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose SBRT and VMAT technique | Radiation | One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with spine metastases
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| Name | Affiliation | Role |
|---|---|---|
| Ciro Franzese, MD | Istituto Clinico Humanitas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Rozzano | Milan | 20089 | Italy |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 1 year |
| Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4 | 3 months |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |