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

History of Changes

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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:

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.

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.

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.

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

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 May 19, 2013

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