Study of Image-Guided SBRT for Vertebral Metastases

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

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.

Study Overview

• Status: Terminated
• Conditions: Vertebral Metastases
• Intervention / Treatment: Radiation: Single dose SBRT and VMAT technique

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with spine metastases

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vertebral metastases; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	1 year
Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4	3 months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Ciro Franzese, MD, Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2015
• Primary Completion (Actual): February 8, 2022
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: November 27, 2015
• First Posted (Estimate): November 30, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 1460