NCT01908179

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).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

2.5 years

First QC Date

July 23, 2013

Last Update Submit

July 24, 2013

Conditions

Metastatic Brain Tumor

Keywords

Sterotactic Radiosurgery

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with metastatic brain tumors undergoing, or have undergone, sterotactic radiosurgery (SRS)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Medical Center

Seattle, Washington, 98122, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Tracie Granger

CONTACT

206-215-2466tracie.granger@swedish.org

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 25, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations

US(1)