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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Radiation Spine stereotactic body radiotherapy
  Cohort 1 - De novo: Spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions. Cohort 2 - Prior radiotherapy: Risk-adapted spinal cord tolerance based on prior spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.

Primary outcome measures

• Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI) [Time frame: within 5 days of treatment completion]
• Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G [Time frame: within 5 days of treatment completion]
• Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L [Time frame: within 5 days of treatment completion]

Secondary outcome measures (8)

• Pain relief [Time frame: 3 months]
• Pain response [Time frame: 12 months]
• Duration of pain response [Time frame: 12 months]
• Number of safety events [Time frame: 12 months]
• Change in response over time for the FACT-G [Time frame: baseline, 12 months]
• Change in response over time for the EQ-5D-5L [Time frame: baseline, 12 months]
• Functional Assessment of Cancer Therapy-General (FACT-G) [Time frame: 12 months, 24 months]
• EuroQol (EQ-5D-5L) [Time frame: 12 months, 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Miami Cancer Institute at Baptist Health, Inc — Miami

Identifiers

NCT: NCT04802603 · 2020-KOT-003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗