Cyberknife Radiosurgery and Quality of Life | NCT01163539

Studies
Cyberknife Radiosurgery and Quality of Life

NCT01163539

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Jul 1, 2016Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Bone Cancer
Central Nervous System Cancer

Interventions

Not provided

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

ID	Type	Description	Link
SU-07092010-6499	Other Identifier	Stanford University

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jul 14, 2010

First Submission Date that Met QC Criteria

Jul 14, 2010

First Posted Date

Jul 15, 2010Estimated

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

Jun 29, 2016

Last Update Posted Date

Jul 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to look at pain control and QOL improvement after treatment with CK Radiosurgery for spinal metastases.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a spinal metastasis who will be treated with Cyberknife radiosurgery.
There are no age or gender restrictions.
There are no life expectancy restrictions.
Karnofsky Performance Status greater than 40.
Negative pregnancy test or clinically assessed as not pregnant.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients with benign tumors will not be included (neurofibromas, schwannomas, etc.)
Other investigational medications or treatments will be noted, but will not preclude inclusion.
Pregnant or nursing patients will be not be included in the study due to radiation exposure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient must have cancer metastases to the spine. They may have had previous surgical or not surgical treatments. Benign tumors will not be assessed.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Daniel Chang	Stanford University	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D001859	Bone Neoplasms
D016543	Central Nervous System Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided