Study of Image-Guided SBRT for Vertebral Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-05

Study Completion Date

2022-02-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vertebral Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vertebral metastases

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

Single dose SBRT and VMAT technique

Intervention Type RADIATION

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

Interventions

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Single dose SBRT and VMAT technique

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

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No