Bone CancerNCT01163539
Cyberknife Radiosurgery and Quality of Life
An observational study of Bone Cancer and Central Nervous System Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to look at pain control and QOL improvement after treatment with CK Radiosurgery for spinal metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Cancer, Central Nervous System Cancer
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study is to look at pain control and QOL improvement after treatment with CK Radiosurgery for spinal metastases.
- Conditions
- Bone Cancer, Central Nervous System Cancer
- Medical subject headings
- Bone Neoplasms, Central Nervous System Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Daniel Chang, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163539
- Sponsor's protocol ID
- SPN0002
- Other IDs
- SU-07092010-6499
- Status last verified
- Jun 2016
- First submitted
- 14 Jul 2010
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyberknife Radiosurgery and Quality of Life
- ClinicalTrials.gov ID
- NCT01163539
- Acronym / sponsor ID
- SPN0002
- Conditions
- Bone Cancer, Central Nervous System Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at pain control and QOL improvement after treatment with CK Radiosurgery for spinal metastases.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Daniel Chang principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Cancer and Central Nervous System Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.