Study of Image-Guided SBRT for Vertebral Metastases

Istituto Clinico Humanitas26 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Vertebral Metastases

Interventions

Single dose SBRT and VMAT techniqueRADIATION

One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Humanitas Research Hospital

Rozzano, Milan, Italy

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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