Study of Image-Guided SBRT for Vertebral Metastases
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|ClinicalTrials.gov Identifier: NCT02616887|
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : December 19, 2019
|Condition or disease||Intervention/treatment|
|Vertebral Metastases||Radiation: Single dose SBRT and VMAT technique|
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.
|Study Type :||Observational|
|Estimated Enrollment :||59 participants|
|Official Title:||Phase II Study of Image-Guided Single Fraction SBRT With VMAT-FFF Technique for Vertebral Metastases|
|Actual Study Start Date :||November 5, 2015|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
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
One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams.
- Toxicity of single fraction SBRT on spine metastases using CTCAE v.4 [ Time Frame: 1 year ]
- Local control of the treated lesions using Kaplan-Meyer statistical curves [ Time Frame: 1 year ]
- Pain control at treated sites after RT using CTCAE v.4 [ Time Frame: 3 months ]
- Local control of the metastatic disease using Kaplan-Meyer statistical curves [ Time Frame: 3 months ]
- Overall survival of treated patients using Kaplan-Meyer statistical curves [ Time Frame: 1 year ]
- Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4 [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616887
|Contact: Ciro Franzese, MDemail@example.com|
|Humanitas Research Hospital||Recruiting|
|Rozzano, Milan, Italy, 20089|
|Contact: Ciro Franzese, MD +390282247454 firstname.lastname@example.org|
|Sub-Investigator: Piera Navarria, MD|
|Sub-Investigator: Francesco Costa, MD|
|Principal Investigator:||Ciro Franzese, MD||Istituto Clinico Humanitas|