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

• Conditions: Metastatic Brain Tumor

• Registration Number: NCT01908179
• Lead Sponsor: Swedish Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-07
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-24
• Last Update Submitted: 2013-07-24
• Study First Posted: 2013-07-25
• Last Update Posted: 2013-07-25
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative measures of overall tumor volume will be performed for each subject at the time of SRS	At the time of SRS
Quantitative measures of tumor number will be performed for each subject at the time of SRS	At the time of SRS
Overall survival will be measured for each subject (in weeks from SRS to death)	Post-SRS

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States