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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 19, 2014
Last verified: May 2014
  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: stereotactic body radiation therapy
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)

Resource links provided by NLM:


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 Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (prior radiotherapy)
Patients undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each.
Radiation: stereotactic body radiation therapy
Given in 1 or 5 fractions
Experimental: Group 2 (no prior radiotherapy)
Patients undergo 1 fraction of SBRT over 30-90 minutes.
Radiation: stereotactic body radiation therapy
Given in 1 or 5 fractions

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed cancer as determined by biopsy, prior surgery, or re-biopsy at the discretion of the treating physician
  • Must have localized spinal metastasis, defined as 1 of the following:

    • Solitary lesion
    • Lesion that spans 2 contiguous levels
    • Lesion with a para-spinal component
    • Lesion with up to 3 separate single vertebral levels
  • Visual analog scoring system pain score ≥ 4 at any of the planned treatment site(s)
  • No instability of the spine requiring instrumentation, as judged by a neurosurgeon
  • No compression fractures, paraspinal extension, or bony fragments
  • No radiation sensitive histology (e.g., lymphoma, multiple myeloma, or plasmacytoma)
  • Epidural, spinal nerve, and/or cord compression by MRI allowed

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Platelet count normal
  • PT/PTT normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be or have been ambulatory within 1 week prior to study treatment
  • No history of significant psychiatric illness
  • No severe, active co-morbidity that would preclude vertebroplasty or stereotactic body radiotherapy, defined as any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring IV antibiotics
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

PRIOR CONCURRENT THERAPY:

  • More than 1 week since prior chemotherapy
  • At least 3 months since prior fractionated radiotherapy to the planned treatment site(s)
  • No planned systemic treatment within 1 week after study treatment
  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:
No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00855803     History of Changes
Other Study ID Numbers: CDR0000634640, SCCC-112008-022, SBRT Spine
Study First Received: March 3, 2009
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

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
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2014