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

NCT ID: NCT01778764

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Brain and Nervous System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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retrospective cohort

retrospective follow-up of patients treated since 2006

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Steven D Chang

ROBERT C. AND JEANNETTE POWELL NEUROSCIENCES PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Chang

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

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IRB-26173

Identifier Type: OTHER

Identifier Source: secondary_id

BRN0022

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-26173

Identifier Type: -

Identifier Source: org_study_id

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