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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00855803
First received: March 3, 2009
Last updated: March 2, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: radiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Pain [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months


Secondary Outcome Measures:
  • pain response [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Duration of pain response as measured by VAS at 2 weeks, at 1, 3, and 6 months,

  • Overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Overall survival

  • daily function [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Time to functional decline as measured by the Brief Pain Inventory at baseline

  • Quality of life [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Quality of life as measured by the FACT-G and EQ-5D questionnaires at baseline and at 1, 3, 6, and 12 months


Estimated Enrollment: 42
Study Start Date: February 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 radiation

Intervention:

Patients had prior radiotherapy will undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each.

Radiation: radiation
Given in 1 or 5 fractions
Other Name: stereotactic body radiation therapy
Experimental: Group 2 radiation

Intervention:

Patients has no prior radiotherapy will undergo 1 fraction of SBRT over 30-90 minutes.

Radiation: radiation
Given in 1 or 5 fractions
Other Name: stereotactic body radiation therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855803

Contacts
Contact: Robert Timmerman, MD 214-645-8525
Contact: Jean Wu, MSN 214-645-8525

Locations
United States, Texas
University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robert D. Timmerman, MD Simmons Cancer Center
  More Information

Additional Information:
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00855803     History of Changes
Other Study ID Numbers: STU 072010-134 
Study First Received: March 3, 2009
Last Updated: March 2, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Texas Southwestern Medical Center:
spinal cord metastases
unspecified adult solid tumor, protocol specific
pain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on December 07, 2016