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Phase I Compare OS in Post-CyberKnife Radiosurgery Tx in 1-3 VS 4 or More Brain Metastases

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ClinicalTrials.gov Identifier: NCT01778764
Recruitment Status : Withdrawn
First Posted : January 29, 2013
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Steven D Chang, Stanford University

Brief 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. 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.

Condition or disease
Brain and Nervous System

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Comparison of Overall Survival Post-CyberKnife Radiosurgery Treatment of Patients With 1-3 Versus 4 or More Brain Metastases
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Group/Cohort
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



Primary Outcome Measures :
  1. Overall survival [ Time Frame: until death or the end of follow-up, whichever comes first. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with all types of primary cancers which have metastasized to the brain.
Criteria

Inclusion Criteria:

  1. 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
  2. a Karnofsky performance status (KPS) score of greater than or equal to 60.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778764


Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Steven Chang Stanford University
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Responsible Party: Steven D Chang, ROBERT C. AND JEANNETTE POWELL NEUROSCIENCES PROFESSOR, Stanford University
ClinicalTrials.gov Identifier: NCT01778764    
Other Study ID Numbers: IRB-26173
IRB-26173 ( Other Identifier: Stanford IRB )
BRN0022 ( Other Identifier: OnCore )
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: January 2022
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases