Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy

• ClinicalTrials.gov Identifier: NCT00328510
• Recruitment Status: Completed
• First Posted: May 22, 2006
• Results First Posted: August 19, 2013
• Last Update Posted: November 29, 2016
• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Information provided by (Responsible Party): Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial Comparing Two Forms of Immobilization of the Head for Fractioned Stereotactic Radiotherapy
• Study Start Date: February 2005
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability [ Time Frame: Measurements taken during SRT ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients who are eligible for fractionated stereotactic radiotherapy

Exclusion Criteria:

• Severe claustrophobia

Contacts and Locations

Locations

United States, Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

• Principal Investigator: Maria Werner-Wasik, MD; Thomas Jefferson University

More Information

Additional Information:

Kimmel Cancer Center at Thomas Jefferson University 

Publications:

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.

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.

Lopatta E, Liesenfeld SM, Bank P, Wurm R, Günther 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. German.

• Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT00328510
• Other Study ID Numbers: 04U.534; 2004-72 ( Other Identifier: CCRRC )
• First Posted: May 22, 2006
• Results First Posted: August 19, 2013
• Last Update Posted: November 29, 2016
• Last Verified: October 2016

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):

Stereotactic radiotherapy

Additional relevant MeSH terms:

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases