NCT02265549

Brief Summary

Published prognostic scores have limitations in prediction of long term survival after stereotactic radiotherapy for brain metastases. Moreover, no validated tools are available for prediction of local failure. The value of radiomics is evaluated in this perspective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

October 1, 2014

Last Update Submit

January 25, 2018

Conditions

Keywords

Metastases,NeoplasmCerebral

Outcome Measures

Primary Outcomes (2)

  • Sensitive value of 12 months survival after stereotactic radiotherapy for brain metastases with radiomics

    Sensitivity of 12 months survival after stereotactic radiotherapy for brain metastases with radiomics. Radiomics is a tool to analyze tumor characteristics based on CT and MR images.

    1 year

  • Sensitive value of 12 months local failure after stereotactic radiotherapy for brain metastases with radiomics

    Sensitivity of 12 months local failure after stereotactic radiotherapy for brain metastases with radiomics. Radiomics is a tool to analyze tumor characteristics based on CT and MR images.

    1 year

Secondary Outcomes (3)

  • Specificity of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.

    1 year

  • Positive predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.

    1 year

  • Negative predictive value of 12 months survival and local failure after stereotactic radiotherapy for brain metastases with radiomics.

    1 year

Other Outcomes (2)

  • Area under the curve of published prognostic scores

    1 year

  • Mismatch rate of published prognostic scores

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with 1 upto 4 brain metastases treated with SRT

You may qualify if:

  • Cerebral metastasized patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastro Clinic

Maastricht, 6229 ET, Netherlands

Location

Related Publications (3)

  • Zindler JD, Rodrigues G, Haasbeek CJ, De Haan PF, Meijer OW, Slotman BJ, Lagerwaard FJ. The clinical utility of prognostic scoring systems in patients with brain metastases treated with radiosurgery. Radiother Oncol. 2013 Mar;106(3):370-4. doi: 10.1016/j.radonc.2013.01.015. Epub 2013 Mar 20.

  • Rodrigues G, Zindler J, Warner A, Lagerwaard F. Recursive partitioning analysis for the prediction of stereotactic radiosurgery brain metastases lesion control. Oncologist. 2013;18(3):330-5. doi: 10.1634/theoncologist.2012-0316. Epub 2013 Feb 19.

  • Aerts HJ, Velazquez ER, Leijenaar RT, Parmar C, Grossmann P, Carvalho S, Bussink J, Monshouwer R, Haibe-Kains B, Rietveld D, Hoebers F, Rietbergen MM, Leemans CR, Dekker A, Quackenbush J, Gillies RJ, Lambin P. Decoding tumour phenotype by noninvasive imaging using a quantitative radiomics approach. Nat Commun. 2014 Jun 3;5:4006. doi: 10.1038/ncomms5006.

MeSH Terms

Conditions

Neoplasm MetastasisNeoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 16, 2014

Study Start

May 1, 2014

Primary Completion

September 4, 2014

Study Completion

September 4, 2014

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations