NCT00185666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

July 14, 2010

Status Verified

July 1, 2010

Enrollment Period

4 years

First QC Date

September 12, 2005

Last Update Submit

July 12, 2010

Conditions

Spinal Cord CancerBrain (Nervous System) Cancers

Outcome Measures

Primary Outcomes (1)

  • Usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions

    completed

Interventions

Stereotactic radiosurgeryPROCEDURE

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients younger than 5 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (4)

  • 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.

    PMID: 15350039BACKGROUND

  • 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.

    PMID: 17257702RESULT

  • 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.

    PMID: 16575331RESULT

  • 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.

    PMID: 16723887RESULT

MeSH Terms

Conditions

Neurologic ManifestationsNeoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Iris Catrice Gibbs

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

May 1, 2002

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

July 14, 2010

Record last verified: 2010-07

Locations

US(1)