Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy
NCT ID: NCT00328510
Last Updated: 2016-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
83 participants
INTERVENTIONAL
2005-02-28
2009-09-30
Brief Summary
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Detailed Description
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1\) To compare the efficacy of two commonly used, generally accepted forms of immobilization for the treatment of lesions in the head with fractionated stereotactic radiotherapy. Specifically, this study will use the ExacTRAC kilovoltage imaging system to assess positioning accuracy for these two systems.
OUTLINE:
Two routinely used methods of immobilization, which differ in their approach to reproduce head position from day-to-day are the Gill-Thomas-Cosman (GTC)frame and the BrainLab thermoplastic mask. The GTC frame fixates on the patient upper detention and thus us in direct mechanical contact with the cranium. The BrainLab mask is a two-part masking system custom-fitted to the front and back of the participant's head. After patients sign an IRB-approved informed consent form, eligible participants are either randomized to either the GTC frame or the mask for their course of SRT. Participants are treated as per standard procedure; however, prior to each treatment, a set of digital kV images (ExacTrac, BrainLabAB, Germany) is taken. These images are fused with reference digitally constructed radiographs obtained from treatment planning CT to yield lateral, longitudinal, and vertical deviations of isocenter and head rotations about respective axes. The primary endpoint of the study is to compare the two systems with respect to mean and standard deviations (SDs) using the distance to isocenter measure.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GTC Frame
Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
GTC frame
Stereotactic radiation therapy
BrainLab thermoplastic mask
Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
Thermoplastic facemask
Stereotactic radiation therapy
Interventions
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GTC frame
Thermoplastic facemask
Stereotactic radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Maria Werner-Wasik, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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Shiu A, Parker B, Ye JS, Lii J. An integrated treatment delivery system for CSRS and CSRT and clinical applications. J Appl Clin Med Phys. 2003 Autumn;4(4):261-73. doi: 10.1120/jacmp.v4i4.2496.
Burton KE, Thomas SJ, Whitney D, Routsis DS, Benson RJ, Burnet NG. Accuracy of a relocatable stereotactic radiotherapy head frame evaluated by use of a depth helmet. Clin Oncol (R Coll Radiol). 2002 Feb;14(1):31-9. doi: 10.1053/clon.2001.0001.
Lopatta E, Liesenfeld SM, Bank P, Wurm R, Gunther R, Wiezorek T, Wendt TG. [Improved patient repositioning accuracy by integrating an additional jaw fixation into a high precision face mask system in stereotactic radiotherapy of the head]. Strahlenther Onkol. 2003 Aug;179(8):571-5. doi: 10.1007/s00066-003-0941-3. German.
Related Links
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Kimmel Cancer Center at Thomas Jefferson University
Other Identifiers
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2004-72
Identifier Type: OTHER
Identifier Source: secondary_id
04U.534
Identifier Type: -
Identifier Source: org_study_id