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Serial CT Scans in Fractionated Stereotactic Radiotherapy

Primary Purpose

Brain Tumor

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Relocatable fixation system
Sponsored by
Maastricht Radiation Oncology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring brain tumor, fractionated stereotactic radiotherapy, fixationsystems, repositioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of brain tumor Fractionated stereotactic radiotherapy Exclusion Criteria: -

Sites / Locations

  • Maastricht Radiation Oncology

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

No secondary measures.

Full Information

First Posted
September 9, 2005
Last Updated
June 29, 2009
Sponsor
Maastricht Radiation Oncology
Collaborators
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00181350
Brief Title
Serial CT Scans in Fractionated Stereotactic Radiotherapy
Official Title
Serial CT Scans for the Evaluation of Two Different Relocatable Fixation Systems in Fractionated Stereotactic Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht Radiation Oncology
Collaborators
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Stereotactic conformal radiotherapy (SCRT) combines the precision of the stereotactically guided tumor localisation and the radiobiological advantages of the fractionation. This implies an highly accurate repositioning of the isocenter of the cerebral target at the isocenter of the linac gantry and couch + 30 times. In the use of stereotactic conformal radiotherapy (SCRT) accuracy is the mainstay for the treatment of brain tumours. The reason are reduced safety margins around the tumour (or no margins) in order to reduce normal tissue dose. 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. The first approach will be based on the BrainLAB thermoplastic masque (the masque with (= standard fixation) and without a custom made bite-block), the second will use the BrianLAB relocatable frame with the bite- block and a home made fixation system. Repositioning accuracy will be evaluated in a randomized manner patient-dependent and independent with the two fixation systems mentioned above. The rationale is to determine the margins to define the planning target volume (PTV), it is necessary to know the set-up accuracy of the immobilization system. An overestimation of the PTV would lead to possible toxicity and an underestimation could lead to a geographical miss. The main endpoint of this trial will be the accurate reproducibility of the fixation system evaluated by repeated CT scan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
brain tumor, fractionated stereotactic radiotherapy, fixationsystems, repositioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Relocatable fixation system
Primary Outcome Measure Information:
Title
CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.
Secondary Outcome Measure Information:
Title
No secondary measures.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of brain tumor Fractionated stereotactic radiotherapy Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitta Baumert, PHD
Organizational Affiliation
Maastricht Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht Radiation Oncology
City
Heerlen
State/Province
Limburg
ZIP/Postal Code
6419 PC
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22194025
Citation
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.
Results Reference
derived

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Serial CT Scans in Fractionated Stereotactic Radiotherapy

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