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Cyberknife Radiosurgery and Quality of Life

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.
 
ClinicalTrials.gov Identifier: NCT01163539
Recruitment Status : Terminated
First Posted : July 15, 2010
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date July 14, 2010
First Posted Date July 15, 2010
Last Update Posted Date July 1, 2016
Study Start Date July 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01163539 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cyberknife Radiosurgery and Quality of Life
Official Title Cyberknife Radiosurgery and Quality of Life
Brief Summary The purpose of this study is to look at pain control and QOL improvement after treatment with CK Radiosurgery for spinal metastases.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient must have cancer metastases to the spine. They may have had previous surgical or not surgical treatments. Benign tumors will not be assessed.
Condition
  • Bone Cancer
  • Central Nervous System Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 29, 2016)
15
Original Estimated Enrollment
 (submitted: July 14, 2010)
70
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with a spinal metastasis who will be treated with Cyberknife radiosurgery.
  • There are no age or gender restrictions.
  • There are no life expectancy restrictions.
  • Karnofsky Performance Status greater than 40.
  • Negative pregnancy test or clinically assessed as not pregnant.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients with benign tumors will not be included (neurofibromas, schwannomas, etc.)
  • Other investigational medications or treatments will be noted, but will not preclude inclusion.
  • Pregnant or nursing patients will be not be included in the study due to radiation exposure.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01163539
Other Study ID Numbers SPN0002
SU-07092010-6499 ( Other Identifier: Stanford University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Steven Daniel Chang Stanford University
PRS Account Stanford University
Verification Date June 2016