Cyberknife Precision Radiation Delivery System for Tumors... | NCT00185666

Studies
Cyberknife Precision Radiation Delivery System for Tumors of the Spine

NCT00185666

Sponsor

Stanford University

Status

Completed

Last Update Posted

Jul 14, 2010Estimated

Enrollment

200Actual

Phase

Phase 1Phase 2

Conditions

Spinal Cord Cancer
Brain (Nervous System) Cancers

Interventions

Stereotactic radiosurgery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2010

Last Update Posted Date

Jul 14, 2010Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Name	Type	Description	Arm Group Labels	Other Names
Stereotactic radiosurgery	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions		completed

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iris Catrice Gibbs	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15350039	Background	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.
17257702	Result	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.

ID	Term
D009461	Neurologic Manifestations
D009369	Neoplasms

ID	Term
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures