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Clinical Trials/NCT01908179
NCT01908179
Unknown
Not Applicable

Markers of Prognosis and Response to Therapy in Patients With Metastatic Brain Tumors Undergoing Stereotactic Radiosurgery (SRS)

Swedish Medical Center1 site in 1 country100 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic Brain Tumor
Sponsor
Swedish Medical Center
Enrollment
100
Locations
1
Primary Endpoint
Quantitative measures of overall tumor volume will be performed for each subject at the time of SRS
Last Updated
12 years ago

Overview

Brief Summary

This registry study will evaluate patients with metastatic brain tumors undergoing, or having undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical outcomes will be evaluated at the 3, 6 and 12-month time points. Clinical data, SRS treatment data, and imaging data (including anatomic and advanced imaging sequences obtained prior to and serially following SRS) will be archived in an online informatics platform, specifically a metastatic brain tumor registry known as the Comprehensive Neuro-oncology Data Repository for Metastatic Tumors (CONDR - Mets).

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
July 2015
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients (\>18 yo) with a pathological diagnosis of metastatic brain cancer
  • Participants must have \>4 tumors felt to require stereotactic radiosurgery
  • Karnofsky scale of \> 70 at the time of initial treatment
  • Age \< 80

Exclusion Criteria

  • Karnofsky scale \<70
  • Age \> 80
  • Inability to undergo MR imaging studies

Outcomes

Primary Outcomes

Quantitative measures of overall tumor volume will be performed for each subject at the time of SRS

Time Frame: At the time of SRS

Quantitative measures of tumor number will be performed for each subject at the time of SRS

Time Frame: At the time of SRS

Overall survival will be measured for each subject (in weeks from SRS to death)

Time Frame: Post-SRS

Secondary Outcomes

  • Measures of ADC, rCBV, MTT and ktrans will be performed for each treated tumor at treatment and at 6 months following SRS(6 months post SRS)
  • Time to progression (in weeks) will be measured for each treated tumor(Post-SRS)
  • Diagnosis of progression or radiation necrosis (made on clinical reflection at study's end) will be determined for tumors where diagnosis is in question at 6 and 12 months after SRS(12 months post-SRS)

Study Sites (1)

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