Serial CT Scans in Fractionated Stereotactic Radiotherapy
|First Received Date ICMJE||September 9, 2005|
|Last Updated Date||June 29, 2009|
|Start Date ICMJE||November 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00181350 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||No secondary measures.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Serial CT Scans in Fractionated Stereotactic Radiotherapy|
|Official Title ICMJE||Serial CT Scans for the Evaluation of Two Different Relocatable Fixation Systems in Fractionated Stereotactic Radiotherapy|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Brain Tumor|
|Intervention ICMJE||Device: Relocatable fixation system|
|Study Arm (s)||Not Provided|
|Publications *||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. Epub 2011 Dec 24.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||July 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Netherlands|
|NCT Number ICMJE||NCT00181350|
|Other Study ID Numbers ICMJE||P03.1426L|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Maastricht Radiation Oncology|
|Collaborators ICMJE||Maastricht University Medical Center|
|Information Provided By||Maastricht Radiation Oncology|
|Verification Date||June 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP