- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00185666
Cyberknife Precision Radiation Delivery System for Tumors of the Spine
July 12, 2010 updated by: Stanford University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions
Time Frame: completed
|
completed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Iris Catrice Gibbs, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gibbs IC, Chang SD. Radiosurgery and radiotherapy for sacral tumors. Neurosurg Focus. 2003 Aug 15;15(2):E8. doi: 10.3171/foc.2003.15.2.8.
- Gibbs IC, Kamnerdsupaphon P, Ryu MR, Dodd R, Kiernan M, Chang SD, Adler JR Jr. Image-guided robotic radiosurgery for spinal metastases. Radiother Oncol. 2007 Feb;82(2):185-90. doi: 10.1016/j.radonc.2006.11.023. Epub 2007 Jan 24.
- Dodd RL, Ryu MR, Kamnerdsupaphon P, Gibbs IC, Chang SD Jr, Adler JR Jr. CyberKnife radiosurgery for benign intradural extramedullary spinal tumors. Neurosurgery. 2006 Apr;58(4):674-85; discussion 674-85. doi: 10.1227/01.NEU.0000204128.84742.8F.
- Sinclair J, Chang SD, Gibbs IC, Adler JR Jr. Multisession CyberKnife radiosurgery for intramedullary spinal cord arteriovenous malformations. Neurosurgery. 2006 Jun;58(6):1081-9; discussion 1081-9. doi: 10.1227/01.NEU.0000215891.25153.BA.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2002
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
July 14, 2010
Last Update Submitted That Met QC Criteria
July 12, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- SPN0001
- NCT00185666
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.