Health TrialsbyHealthPanel

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

ConditionsSpine MetastasesMetastasis Spine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Spine stereotactic body radiotherapy

    Radiation

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: RadiotherapyOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)

Assess the change in the feasibility and tolerability response of dose-escalated spine SBRT in patients with de novo or recurrent spine metastases with the Brief Pain Inventory questionnaire. The scale is from 0-10.

Time frame
within 5 days of treatment completion
2

Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G

4 scales: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and functional well-being (7 items). The FACT-G, developed by Cella, et al.20 is a five point patient self-rating scale (from "not at all" to "very much").

Time frame
within 5 days of treatment completion
3

Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L

Consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems

Time frame
within 5 days of treatment completion

Secondary outcomes

1

Pain relief

To assess the rate of complete or partial pain relief at 3 months using the Numerical Rating Pain Scale. Complete pain relief is defined as a pain score of 0 at the index site at 3 months post-treatment. Complete pain relief is based on no increase in narcotic pain medication, and a self-rated score of 0. Partial pain relief is defined as a reduction in the numerical pain score of at least 2 points from the baseline NRPS at the index site, as long as none of the other treated lesions have increased in pain score and as long as the patient did not require an increase in the level of narcotic pain medication.

Time frame
3 months
2

Pain response

To assess the rapidity of pain response using the Numerical Rating Pain Scale. Pain response will be categorized as following: 1) complete response, post-treatment pain score of 0 at the index site; 2) partial response, post-treatment improvement of at least 3 points at the index site; 3) stable response, post-treatment pain score within 3 points of the initial pain score at the index site, or 4) progressive response, a post-treatment increase of at least 3 points at the index site.

Time frame
12 months
3

Duration of pain response

To assess the duration of pain response using the Numerical Rating Pain Scale. The NRPS is an 11-point scale (0-10). Patients are instructed that 0 indicates no pain and that 10 indicates the worst pain imaginable. In general, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Patients will be instructed to report the pain score of each treated site. Patients can complete the NRPS in approximately 1 minute.

Time frame
12 months
4

Number of safety events

To assess the safety and tolerability of treatment using CTCAE v5.0 criteria

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baptist Health South Florida

Lead sponsor

Source ClinicalTrials.gov
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