Stereotactic Radiosurgery (SRS) for Spine Metastases (SRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00593320
Recruitment Status : Terminated (Due to low accrual)
First Posted : January 15, 2008
Results First Posted : March 4, 2015
Last Update Posted : March 4, 2015
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
This study will evaluate the most effective radiation dose. Patients will be randomized (like flipping a coin) to receive either low dose stereotactic radiotherapy (defined as "14 Gy") or high dose stereotactic radiotherapy (defined as 18 Gy).

Condition or disease Intervention/treatment Phase
Spinal Metastases Radiation: Stereotactic Radiosurgery Not Applicable

Detailed Description:
This study will evaluate the pain control and the quality of life of patients with spinal metastases using stereotactic radiotherapy. Stereotactic radiotherapy is referred to as "targeted therapy". It uses special equipment to position the patient and guide the focused beams of radiation toward the cancer and away from normal surrounding tissue. This higher dose technique may work better to kill cancer cells with fewer side effects than standard radiation therapy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases
Study Start Date : September 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Active Comparator: 1
Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
Radiation: Stereotactic Radiosurgery
Active Comparator: 2
High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
Radiation: Stereotactic Radiosurgery

Primary Outcome Measures :
  1. Pain Control Rate as Measured by the The Brief Pain Inventory [ Time Frame: 6 months after completion of treatment ]
    The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.

  2. Musculoskeletal Function as Measured by the Oswestry Disability Index [ Time Frame: 6 months after completion of treatment ]
    The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.

  3. Quality of Life as Measured by the FACT-CNS Questionnaire [ Time Frame: 6 months after completion of treatment ]

    The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns.

    Participants can choose 0 (Not At All) up to 4 (Very Much) for each question.

Secondary Outcome Measures :
  1. Local Control Rate [ Time Frame: 6 months after end of treatment ]
    Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent.
  • Age greater than or equal to 18 years old.
  • Prior histologically-proven, non-hematogenous malignancy (Specific exclusions are multiple myeloma and lymphoma).
  • Radiographic evidence of one or two non-contiguous spinal metastases amenable to SRS.
  • Metastatic disease must be symptomatic (causing either pain or neurologic symptoms).
  • Maximum tumor size less than or equal to 5 cm.
  • Zubrod performance status of less than or equal to 3.
  • Life expectancy of greater than or equal to 3 months.
  • Women/Men of childbearing potential must use effective contraception.

Exclusion Criteria:

  • No prior radiation delivered to the involved area
  • No evidence of spinal instability requiring urgent surgical intervention.
  • No evidence of spinal cord compression requiring emergent surgical or radiotherapeutic intervention.
  • No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.Concomitant is defined as within 3 days before or after radiosurgery.
  • No pregnant or lactating women.
  • No active systemic infection.
  • No evidence of myelopathy or cauda equina syndrome on clinical evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00593320

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Jeffrey Bradley, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine Identifier: NCT00593320     History of Changes
Other Study ID Numbers: 07-0658
First Posted: January 15, 2008    Key Record Dates
Results First Posted: March 4, 2015
Last Update Posted: March 4, 2015
Last Verified: February 2015

Keywords provided by Washington University School of Medicine:

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes