Brain and Nervous SystemNCT01778764
Phase I Compare OS in Post-CyberKnife Radiosurgery Tx in 1-3 VS 4 or More Brain Metastases
An observational study of Brain and Nervous System, run by Stanford University.
Trial summary
The investigators will learn from this study if the CyberKnife radiosurgery (CK RS) treatment of patients with 1-3 versus 4 or more brain metastases results in the same overall survivals. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Brain and Nervous System
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2019
- 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 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with all types of primary cancers which have metastasized to the brain.
Who may be able to join
- the presence of a tumor metastasis or tumor metastases to the brain as manifested by the neurological examination and visibility of the metastatic lesion(s) on MRI and CT scans
- a Karnofsky performance status (KPS) score of greater than or equal to 60.
Who cannot join
- The exclusion criteria are the converse of the above, i.e. patients without a brain tumor metastasis or brain tumor metastases or a KPS of less than 60.
About this study
Official title: A Comparison of Overall Survival Post-CyberKnife Radiosurgery Treatment of Patients With 1-3 Versus 4 or More Brain Metastases
The investigators will learn from this study if the CyberKnife radiosurgery (CK RS) treatment of patients with 1-3 versus 4 or more brain metastases results in the same overall survivals. The importance of this new knowledge will be to determine the treatment efficacy of CK RS with 1-3 versus 4 or more brain metastases. The outcome of this trial would give data to support either the continuation or modification of the CK RS treatment of patients with brain metastases.
Read the detailed description
This is registry-based cohort study of patients with brain metastases treated at Stanford University Medical Center (SUMC) with CyberKnife radiosurgery (CK RS). It has two components: (1) a retrospective follow-up of patients treated since 2006, and (2) the accrual of a new cohort of patients treated over a 5-year period from January 15, 2013 to December 31, 2017 and followed for at least one year thereafter. The primary aim of this study is to estimate the effect of the number of brain tumor metastases on survival after adjusting for known risk factors for mortality.
- Conditions
- Brain and Nervous System
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| retrospective cohort | retrospective follow-up of patients treated since 2006 | |
| prospective cohort | patients treated over a 5-year period from January 15, 2013 to December 31, 2017 and followed for at least one year thereafter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: until death or the end of follow-up, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startOct 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Nervous SystemStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven D Chang, Stanford University
- Investigators
- Steven Chang, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778764
- Sponsor's protocol ID
- IRB-26173
- Other IDs
- IRB-26173, BRN0022
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2013
- Last updated
- 4 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Overall Survival Post-CyberKnife Radiosurgery Treatment of Patients With 1-3 Versus 4 or More Brain Metastases
- ClinicalTrials.gov ID
- NCT01778764
- Acronym / sponsor ID
- IRB-26173
- Conditions
- Brain and Nervous System
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Jan 2013 (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 investigators will learn from this study if the CyberKnife radiosurgery (CK RS) treatment of patients with 1-3 versus 4 or more brain metastases results in the same overall survivals. The importance of this new knowledge will be to determine the treatment efficacy of CK RS with 1-3 versus 4 or more brain metastases. The outcome of this trial would give data to support either the continuation or modification of the CK RS treatment of patients with brain metastases.
Detailed description
This is registry-based cohort study of patients with brain metastases treated at Stanford University Medical Center (SUMC) with CyberKnife radiosurgery (CK RS). It has two components: (1) a retrospective follow-up of patients treated since 2006, and (2) the accrual of a new cohort of patients treated over a 5-year period from January 15, 2013 to December 31, 2017 and followed for at least one year thereafter. The primary aim of this study is to estimate the effect of the number of brain tumor metastases on survival after adjusting for known risk factors for mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective cohort | – | –retrospective follow-up of patients treated since 2006 |
| prospective cohort | – | –patients treated over a 5-year period from January 15, 2013 to December 31, 2017 and followed for at least one year thereafter |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with all types of primary cancers which have metastasized to the brain.
Key inclusion criteria (2 listed)
- the presence of a tumor metastasis or tumor metastases to the brain as manifested by the neurological examination and visibility of the metastatic lesion(s) on MRI and CT scans
- a Karnofsky performance status (KPS) score of greater than or equal to 60.
Key exclusion criteria (1 listed)
- The exclusion criteria are the converse of the above, i.e. patients without a brain tumor metastasis or brain tumor metastases or a KPS of less than 60.
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
Overall survival
Time frame: until death or the end of follow-up, whichever comes first.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
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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 Chang principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Nervous System, run by Stanford University.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Overall survival (time frame: until death or the end of follow-up, whichever comes first.). It is what the study was designed to measure, not a finding.
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 4 Feb 2022.