Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00328510
First received: May 19, 2006
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

Fractionated stereotactic radiotherapy (SRT) requires extremely precise and reproducible immobilization of the patient's head. This randomized study compares the efficacy of two commonly used forms of immobilization used for SRT.


Condition Intervention Phase
Patients Receiving Fractionated Stereotactic Radiotherapy
for Brain Tumors
Device: GTC frame
Device: Thermoplastic facemask
Radiation: Stereotactic radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Two Forms of Immobilization of the Head for Fractioned Stereotactic Radiotherapy

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability [ Time Frame: Measurements taken during SRT ] [ Designated as safety issue: No ]
    This study uses the ExacTRAC imaging system to assess positioning of frame or mask during SRT. Images yield lateral, longitudinal, and vertical deviations of the isocenter as well as head rotations about respective axes.


Enrollment: 83
Study Start Date: February 2005
Study Completion Date: September 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GTC Frame
Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
Device: GTC frame Radiation: Stereotactic radiation therapy
Other Name: SRT
Experimental: BrainLab thermoplastic mask
Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
Device: Thermoplastic facemask Radiation: Stereotactic radiation therapy
Other Name: SRT

Detailed Description:

PRIMARY OBJECTIVE:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are eligible for fractionated stereotactic radiotherapy

Exclusion Criteria:

  • Severe claustrophobia
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00328510

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Maria Werner-Wasik, MD Thomas Jefferson University