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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
Results First Received: February 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Spinal Metastases
Intervention: Radiation: Stereotactic Radiosurgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to participant enrollment on 11/06/2007 and closed to participants enrollment on 03/26/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1: Low Dose Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
Arm 2: High Dose High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy

Participant Flow:   Overall Study
    Arm 1: Low Dose   Arm 2: High Dose
STARTED   1   1 
COMPLETED   1   1 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1: Low Dose Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
Arm 2: High Dose High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
Total Total of all reporting groups

Baseline Measures
   Arm 1: Low Dose   Arm 2: High Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   1   2 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   1   1   2 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   1   1   2 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   1   1   2 


  Outcome Measures
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1.  Primary:   Pain Control Rate as Measured by the The Brief Pain Inventory   [ Time Frame: 6 months after completion of treatment ]

2.  Primary:   Musculoskeletal Function as Measured by the Oswestry Disability Index   [ Time Frame: 6 months after completion of treatment ]

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

4.  Secondary:   Local Control Rate   [ Time Frame: 6 months after end of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeffrey Bradley, M.D.
Organization: Washington University School of Medicine
phone: 314-362-8502
e-mail: jbradley@radonc.wustl.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00593320     History of Changes
Other Study ID Numbers: 07-0658
Study First Received: January 2, 2008
Results First Received: February 18, 2015
Last Updated: February 18, 2015
Health Authority: United States: Institutional Review Board