Cyberknife Precision Radiation Delivery System for Tumors of the Spine

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185666
First received: September 12, 2005
Last updated: July 12, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to determine the usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions.


Condition Intervention Phase
Spinal Cord Cancer
Brain (Nervous System) Cancers
Procedure: Stereotactic radiosurgery
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cyberknife Precision Radiation Delivery System for Tumors of the Spine

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions [ Time Frame: completed ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 2002
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Intra-axial, extra-axial, or vertebral spinal lesion

  • Age > 5
  • Histologic confirmation of malignant primary lesion or radiographic diagnosis of benign or vascular spinal lesion
  • No rapidly deteriorating symptoms of spinal cord compression
  • No instability of the spine
  • Life expectancy > 6 months

Exclusion Criteria:- Patients without tumors of the spine

- Patients younger than 5 years old

  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: NCT00185666

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Iris Catrice Gibbs Stanford University
  More Information

Publications:
Responsible Party: Iris Catrice Gibbs, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00185666     History of Changes
Other Study ID Numbers: SPN0001, SPN0001
Study First Received: September 12, 2005
Last Updated: July 12, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Cord Diseases
Central Nervous System Neoplasms
Central Nervous System Diseases
Nervous System Diseases
Nervous System Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on August 18, 2014