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Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy

Primary Purpose

Patients Receiving Fractionated Stereotactic Radiotherapy, for Brain Tumors

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GTC frame
Thermoplastic facemask
Stereotactic radiation therapy
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients Receiving Fractionated Stereotactic Radiotherapy focused on measuring Stereotactic radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who are eligible for fractionated stereotactic radiotherapy Exclusion Criteria: Severe claustrophobia

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GTC Frame

BrainLab thermoplastic mask

Arm Description

Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy

Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy

Outcomes

Primary Outcome Measures

Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability
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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2006
Last Updated
October 19, 2016
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT00328510
Brief Title
Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy
Official Title
A Randomized Trial Comparing Two Forms of Immobilization of the Head for Fractioned Stereotactic Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Receiving Fractionated Stereotactic Radiotherapy, for Brain Tumors
Keywords
Stereotactic radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GTC Frame
Arm Type
Experimental
Arm Description
Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
Arm Title
BrainLab thermoplastic mask
Arm Type
Experimental
Arm Description
Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
Intervention Type
Device
Intervention Name(s)
GTC frame
Intervention Type
Device
Intervention Name(s)
Thermoplastic facemask
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiation therapy
Other Intervention Name(s)
SRT
Primary Outcome Measure Information:
Title
Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability
Description
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.
Time Frame
Measurements taken during SRT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are eligible for fractionated stereotactic radiotherapy Exclusion Criteria: Severe claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Werner-Wasik, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14604415
Citation
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.
Results Reference
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PubMed Identifier
11898783
Citation
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.
Results Reference
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PubMed Identifier
14509957
Citation
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.
Results Reference
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Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy

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