Serial CT Scans in Fractionated Stereotactic Radiotherapy

NCT ID: NCT00181350

Last Updated: 2009-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Brain Tumor

Keywords

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brain tumor fractionated stereotactic radiotherapy fixationsystems repositioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Relocatable fixation system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of brain tumor
* Fractionated stereotactic radiotherapy

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Maastricht Radiation Oncology

OTHER

Sponsor Role lead

Principal Investigators

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Brigitta Baumert, PHD

Role: PRINCIPAL_INVESTIGATOR

Maastricht Radiation Oncology

Locations

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Maastricht Radiation Oncology

Heerlen, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 22194025 (View on PubMed)

Other Identifiers

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P03.1426L

Identifier Type: -

Identifier Source: org_study_id