Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column (DESSRT)

Baptist Health South Florida

Status

Enrolling

Conditions

Metastasis Spine

Spine Metastases

Treatments

Radiation: Spine stereotactic body radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04802603

2020-KOT-003

Details and patient eligibility

About

This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques.

In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.

Full description

Given the limitations with conventional external-beam radiotherapy, spine stereotactic radiosurgery was developed as an alternative treatment for localized spine metastasis. Stereotactic radiosurgery is an alternative treatment option to conventional palliative radiotherapy, which has gained acceptance over the last decade. Clinical experience with spine stereotactic radiosurgery has showed high rates of pain control and improvement in neurological function in patients with epidural compression.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Zubrod Performance Status 0-2
Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)
Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)

Exclusion criteria

Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
Non-ambulatory patients
>50% loss of vertebral body height or spinal instability to due pathologic compression fracture
Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
Rapid neurologic decline
Patients for whom an MRI of the spine is medically contraindicated
Pregnant women