NCT00181350

Brief Summary

This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2003

Typical duration for phase_3

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

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

First QC Date

September 9, 2005

Last Update Submit

June 29, 2009

Conditions

Brain Tumor

Keywords

brain tumorfractionated stereotactic radiotherapyfixationsystemsrepositioning

Outcome Measures

Primary Outcomes (1)

  • CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.

Secondary Outcomes (1)

  • No secondary measures.

Interventions

Relocatable fixation systemDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of brain tumor
  • Fractionated stereotactic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht Radiation Oncology

Heerlen, Limburg, 6419 PC, Netherlands

Location

Related Publications (1)

  • Theelen A, Martens J, Bosmans G, Houben R, Jager JJ, Rutten I, Lambin P, Minken AW, Baumert BG. Relocatable fixation systems in intracranial stereotactic radiotherapy. Accuracy of serial CT scans and patient acceptance in a randomized design. Strahlenther Onkol. 2012 Jan;188(1):84-90. doi: 10.1007/s00066-011-0018-7. Epub 2011 Dec 24.

    PMID: 22194025DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Brigitta Baumert, PHD

    Maastricht Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

November 1, 2003

Study Completion

July 1, 2007

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

NL(1)