Cyberknife Precision Radiation Delivery System for Tumors of the Spine

Brain (Nervous System) Cancers Clinical Trial

Official title:

Cyberknife Precision Radiation Delivery System for Tumors of the Spine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185666
• Other study ID #: SPN0001
• Secondary ID: SPN0001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: July 12, 2010
• Start date: May 2002
• Est. completion date: May 2006

Study information

• Verified date: July 2010
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain (Nervous System) Cancers
• Spinal Cord Cancer

Intervention

Procedure:
• Stereotactic radiosurgery

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Gibbs IC, Chang SD. Radiosurgery and radiotherapy for sacral tumors. Neurosurg Focus. 2003 Aug 15;15(2):E8. Review. — View Citation

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. Epub 2007 Jan 24. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions		completed	No