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Clinical Trials/NCT00181350
NCT00181350
Completed
Phase 3

Serial CT Scans for the Evaluation of Two Different Relocatable Fixation Systems in Fractionated Stereotactic Radiotherapy

Maastricht Radiation Oncology1 site in 1 country20 target enrollmentNovember 2003
ConditionsBrain Tumor

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Brain Tumor
Sponsor
Maastricht Radiation Oncology
Enrollment
20
Locations
1
Primary Endpoint
CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2003
End Date
July 2007
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Maastricht Radiation Oncology

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of brain tumor
  • Fractionated stereotactic radiotherapy

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • No secondary measures.

Study Sites (1)

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