Clinical trial NCT04802603: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spine Metastases
Metastasis Spine
Keywords: Localized Metastasis
Spinal Column
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Cohort 1 (De novo) Cohort 2 (Prior radiotherapy)
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)
timeFrame: within 5 days of treatment completion
measure: Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G
timeFrame: within 5 days of treatment completion
measure: Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L
timeFrame: within 5 days of treatment completion
Secondary outcomes:
measure: Pain relief
timeFrame: 3 months
measure: Pain response
timeFrame: 12 months
measure: Duration of pain response
timeFrame: 12 months
measure: Number of safety events
timeFrame: 12 months
measure: Change in response over time for the FACT-G
timeFrame: baseline, 12 months
measure: Change in response over time for the EQ-5D-5L
timeFrame: baseline, 12 months
measure: Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: 12 months, 24 months
measure: EuroQol (EQ-5D-5L)
timeFrame: 12 months, 24 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc
state: Florida
Study officials:
affiliation: Miami Cancer Institute (MCI) at Baptist Health, Inc.
name: Rupesh Kotecha, MD
role: PRINCIPAL_INVESTIGATOR
References: