Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 3

Conditions: for Brain Tumors; Patients Receiving Fractionated Stereotactic Radiotherapy

Treatments: Device: Thermoplastic facemask; Radiation: Stereotactic radiation therapy; Device: GTC frame

Study type: Interventional

Funder types: Other

Identifiers

NCT00328510

2004-72 (Other Identifier)

04U.534

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are eligible for fractionated stereotactic radiotherapy

Exclusion criteria

• Severe claustrophobia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

GTC Frame

Experimental group

Description:

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

Treatment:

Device: GTC frame

Radiation: Stereotactic radiation therapy

BrainLab thermoplastic mask

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic radiation therapy

Device: Thermoplastic facemask