Study of Image-Guided SBRT for Vertebral Metastases

Vertebral Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02616887
• Other study ID #: 1460
• Status: Terminated
• Start date: November 5, 2015
• Est. completion date: February 8, 2022

Study information

• Verified date: May 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: February 8, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Vertebral Metastases

Intervention

Radiation:
• Single dose SBRT and VMAT technique
One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity of single fraction SBRT on spine metastases using CTCAE v.4		1 year
Primary	Local control of the treated lesions using Kaplan-Meyer statistical curves		1 year
Secondary	Pain control at treated sites after RT using CTCAE v.4		3 months
Secondary	Local control of the metastatic disease using Kaplan-Meyer statistical curves		3 months
Secondary	Overall survival of treated patients using Kaplan-Meyer statistical curves		1 year
Secondary	Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4		3 months