NCT01163539

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

1.9 years

First QC Date

July 14, 2010

Last Update Submit

June 29, 2016

Conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with benign tumors will not be included (neurofibromas, schwannomas, etc.)
  • Pregnant or nursing patients will be not be included in the study due to radiation exposure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Bone NeoplasmsCentral Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesNervous System NeoplasmsNervous System Diseases

Study Officials

  • Steven Daniel Chang

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 15, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations