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

Primary Purpose

Spine Metastases, Metastasis Spine

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spine stereotactic body radiotherapy
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spine Metastases focused on measuring Localized Metastasis, Spinal Column

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Miami Cancer Institute at Baptist Health, IncRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radiotherapy

Arm Description

Cohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy

Outcomes

Primary Outcome Measures

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.
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").
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

Secondary Outcome Measures

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.
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.
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.
Number of safety events
To assess the safety and tolerability of treatment using CTCAE v5.0 criteria
Change in response over time for the FACT-G
Comparing the long-term effects (12 months) of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on vertebral bone integrity and spinal cord using the change response for the quality of life questionnaires. Test-retest reliability is high for the subscales with correlation coefficients ranging from a high of .88 for physical well-being to .82 for social and emotional well-being. It is written at the 4th grade reading level, and patients can complete the FACT-G in 5-10 minutes.
Change in response over time for the EQ-5D-5L
Comparing the long-term effects (12 months) of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on vertebral bone integrity and spinal cord using the change response for the quality of life questionnaires. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems.
Functional Assessment of Cancer Therapy-General (FACT-G)
To assess the effect of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on FACT-G. The FACT-G is a commonly used tool measuring the multidimensional components of health related quality of life (HRQOL) across 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, developed by Cella, et al.20 is a five point patient self-rating scale (from "not at all" to "very much").
EuroQol (EQ-5D-5L)
To assess the effect of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on EQ-5D-5L. The EQ-5D is a two-part, patient-completed questionnaire that takes approximately 5 minutes to complete. 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.

Full Information

First Posted
March 15, 2021
Last Updated
July 7, 2023
Sponsor
Baptist Health South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04802603
Brief Title
Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
Acronym
DESSRT
Official Title
Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Metastases, Metastasis Spine
Keywords
Localized Metastasis, Spinal Column

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Cohort 1 (De novo) Cohort 2 (Prior radiotherapy)
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy
Arm Type
Other
Arm Description
Cohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Spine stereotactic body radiotherapy
Intervention Description
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 Measure Information:
Title
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)
Description
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
Title
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G
Description
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
Title
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L
Description
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 Outcome Measure Information:
Title
Pain relief
Description
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
Title
Pain response
Description
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
Title
Duration of pain response
Description
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
Title
Number of safety events
Description
To assess the safety and tolerability of treatment using CTCAE v5.0 criteria
Time Frame
12 months
Title
Change in response over time for the FACT-G
Description
Comparing the long-term effects (12 months) of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on vertebral bone integrity and spinal cord using the change response for the quality of life questionnaires. Test-retest reliability is high for the subscales with correlation coefficients ranging from a high of .88 for physical well-being to .82 for social and emotional well-being. It is written at the 4th grade reading level, and patients can complete the FACT-G in 5-10 minutes.
Time Frame
baseline, 12 months
Title
Change in response over time for the EQ-5D-5L
Description
Comparing the long-term effects (12 months) of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on vertebral bone integrity and spinal cord using the change response for the quality of life questionnaires. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems.
Time Frame
baseline, 12 months
Title
Functional Assessment of Cancer Therapy-General (FACT-G)
Description
To assess the effect of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on FACT-G. The FACT-G is a commonly used tool measuring the multidimensional components of health related quality of life (HRQOL) across 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, developed by Cella, et al.20 is a five point patient self-rating scale (from "not at all" to "very much").
Time Frame
12 months, 24 months
Title
EuroQol (EQ-5D-5L)
Description
To assess the effect of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on EQ-5D-5L. The EQ-5D is a two-part, patient-completed questionnaire that takes approximately 5 minutes to complete. 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
12 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rupesh Kotecha, MD
Phone
786-596-2000
Email
RupeshK@baptisthealth.net
First Name & Middle Initial & Last Name or Official Title & Degree
Maria C Avendano
Phone
17865962000
Email
mariaave@baptisthealth.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, MD
Organizational Affiliation
Miami Cancer Institute (MCI) at Baptist Health, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Cancer Institute at Baptist Health, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, MD
Phone
786-596-2000
Email
RupeshK@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, MD

12. IPD Sharing Statement

Links:
URL
http://baptisthealth.net/cancer-care/home
Description
MCI - Website

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

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