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Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis

Primary Purpose

Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
radiation
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring spinal cord metastases, unspecified adult solid tumor, protocol specific, pain

Eligibility Criteria

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

Eligibility:

Inclusion:

  • Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted)
  • Patients must have a VAS of ≥4 at any of the planned treatment sites
  • Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
  • Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy
  • Narcotic pain prescription and usage information must be available and documented
  • Patients must sign study specific consent
  • Above the age of 18
  • For women of childbearing age a negative pregnancy test is required
  • Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment
  • Zubrod score of 0-2

Exclusion:

  • Patients who have been non-ambulatory for more than 7 days
  • Patients with compression fractures
  • Spine instability requiring fixation
  • Patients with paraspinal extension
  • Patients with bony fragments
  • Planned systemic treatment within one week after treatment.
  • Absence of pathological diagnosis of cancer
  • Chemotherapy within one week of treatment
  • Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma
  • Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Patient had a transmural myocardial infarction within the last 6 months
  • Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
  • PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
  • Platelet count is < 50,000
  • History of significant psychiatric illness

Note: Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up Visual Analog Scoring

Sites / Locations

  • University of Texas Southwestern Medical Center - Dallas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation followed by Vertebroplasty

Arm Description

Intervention: This study is one arm. All patients will undergo radiotherapy followed by vertebroplasty. Patients who had prior radiotherapy will undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. Patients has no prior radiotherapy will undergo 1 fraction of SBRT over 30-90 minutes. The full patient population will then undergo vertebroplasty*. *Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up.

Outcomes

Primary Outcome Measures

Pain Response as Measured by VAS at 3 Months
Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response

Secondary Outcome Measures

Pain Response
Duration of pain response as measured by VAS at 1 month Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response
Overall Survival
Overall survival measured from the date of accession to the date of death. Median times will be reported.
Daily Function
Time to functional decline as measure by the Brief Pain Inventory (BPI) at baseline. BPI has two sections that are scored- pain severity and pain interference. For each of these a numeric scale from 0-10 is used, with 0 being the worst pain and 10 being the worst pain.
Quality of Life Questionnaire Responses
Number of participants who filled out the Functional Assessment of Cancer Therapy- General (FACT-G) and the European Quality of Life Five Dimension (EQ-5D) questionnaires at baseline, 1, 3, 6, and 12 months

Full Information

First Posted
March 3, 2009
Last Updated
February 16, 2022
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00855803
Brief Title
Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis
Official Title
Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebroplasty may help lessen pain and improve quality of life of patients with spinal metastasis. PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.
Detailed Description
OBJECTIVES: Primary To determine the efficacy of stereotactic body radiotherapy in reducing pain at 3 months in patients with localized spinal metastasis. Secondary To determine the duration of pain response at the treated site(s) scored as the time of maximal pain relief to an increase of 2 points on the Visual Analogue Scoring System. To determine the functional preservation of improvement as measured by the Brief Pain Inventory. To prospectively assess quality of life using the FACT-G and EQ-5D questionnaires. To determine the long-term stability of the treated vertebral bone (e.g., fracture, sclerotic change, vertebral body height, or malalignment) as measured by MRI, CT scan, and plain radiographs. OUTLINE: Patients are assigned to 1 of 2 treatment groups according to prior radiotherapy to the planned treatment site(s). Group 1 (prior radiotherapy): Patients undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. Group 2 (no prior radiotherapy): Patients undergo 1 fraction of SBRT over 30-90 minutes. Within 1 month after the initiation of SBRT, patients in both groups undergo percutaneous vertebroplasty. Patients complete pain and quality-of-life questionnaires at baseline and periodically during study. Patients also undergo MRI and CT scan at baseline, at 1, 3, and 6 months, and then every 6 months for 3 years to assess changes in vertebral bone strength and stability. After completion of study therapy, patients are followed at 2 weeks, at 1, 3, and 6 months, and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
spinal cord metastases, unspecified adult solid tumor, protocol specific, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation followed by Vertebroplasty
Arm Type
Experimental
Arm Description
Intervention: This study is one arm. All patients will undergo radiotherapy followed by vertebroplasty. Patients who had prior radiotherapy will undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. Patients has no prior radiotherapy will undergo 1 fraction of SBRT over 30-90 minutes. The full patient population will then undergo vertebroplasty*. *Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up.
Intervention Type
Radiation
Intervention Name(s)
radiation
Other Intervention Name(s)
stereotactic body radiation therapy
Intervention Description
Given in 1 or 5 fractions
Primary Outcome Measure Information:
Title
Pain Response as Measured by VAS at 3 Months
Description
Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Pain Response
Description
Duration of pain response as measured by VAS at 1 month Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response
Time Frame
1 month
Title
Overall Survival
Description
Overall survival measured from the date of accession to the date of death. Median times will be reported.
Time Frame
5 year
Title
Daily Function
Description
Time to functional decline as measure by the Brief Pain Inventory (BPI) at baseline. BPI has two sections that are scored- pain severity and pain interference. For each of these a numeric scale from 0-10 is used, with 0 being the worst pain and 10 being the worst pain.
Time Frame
Baseline
Title
Quality of Life Questionnaire Responses
Description
Number of participants who filled out the Functional Assessment of Cancer Therapy- General (FACT-G) and the European Quality of Life Five Dimension (EQ-5D) questionnaires at baseline, 1, 3, 6, and 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility: Inclusion: Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted) Patients must have a VAS of ≥4 at any of the planned treatment sites Patient with epidural, spinal nerve, and/or cord compression on MRI may be included Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy Narcotic pain prescription and usage information must be available and documented Patients must sign study specific consent Above the age of 18 For women of childbearing age a negative pregnancy test is required Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment Zubrod score of 0-2 Exclusion: Patients who have been non-ambulatory for more than 7 days Patients with compression fractures Spine instability requiring fixation Patients with paraspinal extension Patients with bony fragments Planned systemic treatment within one week after treatment. Absence of pathological diagnosis of cancer Chemotherapy within one week of treatment Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Patient had a transmural myocardial infarction within the last 6 months Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy Platelet count is < 50,000 History of significant psychiatric illness Note: Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up Visual Analog Scoring
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D. Timmerman, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis

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