Study of Image-Guided SBRT for Vertebral Metastases

Istituto Clinico Humanitas

Status: Terminated

Conditions: Vertebral Metastases

Treatments: Radiation: Single dose SBRT and VMAT technique

Study type: Observational

Funder types: Other

Identifiers

NCT02616887

1460

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

26 participants in 1 patient group

Vertebral metastases

Description:

Selected patients with spine metastases are treated with ablative single dose SBRT and VMAT technique in various solid tumors .

Treatment:

Radiation: Single dose SBRT and VMAT technique