NCT01778764

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 24, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

5.2 years

First QC Date

January 24, 2013

Last Update Submit

January 20, 2022

Conditions

Brain and Nervous System

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    until death or the end of follow-up, whichever comes first.

Study Arms (2)

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

Eligibility Criteria

Age21 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with all types of primary cancers which have metastasized to the brain.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Chang

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ROBERT C. AND JEANNETTE POWELL NEUROSCIENCES PROFESSOR

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 29, 2013

Study Start

October 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 4, 2022

Record last verified: 2022-01