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Stereotactic Radiosurgery (SRS) for Spine Metastases (SRS)

This study has been terminated.
(Due to low accrual)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00593320
First received: January 2, 2008
Last updated: February 18, 2015
Last verified: February 2015

January 2, 2008
February 18, 2015
September 2007
March 2010   (final data collection date for primary outcome measure)
  • Pain Control Rate as Measured by the The Brief Pain Inventory [ Time Frame: 6 months after completion of treatment ] [ Designated as safety issue: Yes ]
    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.
  • Musculoskeletal Function as Measured by the Oswestry Disability Index [ Time Frame: 6 months after completion of treatment ] [ Designated as safety issue: No ]
    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.
  • Quality of Life as Measured by the FACT-CNS Questionnaire [ Time Frame: 6 months after completion of treatment ] [ Designated as safety issue: No ]

    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.

The primary endpoint of the primary objective is to estimate the pain control rate, function, and quality of life at 1, 3, and 6 months after treatment. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00593320 on ClinicalTrials.gov Archive Site
Local Control Rate [ Time Frame: 6 months after end of treatment ] [ Designated as safety issue: No ]
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.
The primary endpoint of the secondary objective is to estimate the local control rate at 12 and 24 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Stereotactic Radiosurgery (SRS) for Spine Metastases
Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases
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).
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Metastases
Radiation: Stereotactic Radiosurgery
  • Active Comparator: 1
    Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
    Intervention: Radiation: Stereotactic Radiosurgery
  • Active Comparator: 2
    High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
    Intervention: Radiation: Stereotactic Radiosurgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00593320
07-0658
No
Not Provided
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Jeffrey Bradley, M.D. Washington University School of Medicine
Washington University School of Medicine
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP