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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01778764
First received: January 24, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Phase
Brain and Nervous System
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Comparison of Overall Survival Post-CyberKnife Radiosurgery Treatment of Patients With 1-3 Versus 4 or More Brain Metastases

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Overall survival [ Time Frame: until death or the end of follow-up, whichever comes first. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: January 2013
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778764

Contacts
Contact: Steven Chang 650-723-5573 sdchang@stanford.edu

Locations
United States, California
Stanford University Cancer Institute Not yet recruiting
Stanford, California, United States, 94305
Principal Investigator: Steven Chang         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Steven Chang Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01778764     History of Changes
Other Study ID Numbers: BRN0022, 26173
Study First Received: January 24, 2013
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014