Patients Receiving Fractionated Stereotactic Radiotherapy, for Brain Tumors
Conditions
Keywords
Stereotactic radiotherapy
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.
Interventions
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are eligible for fractionated stereotactic radiotherapy
Exclusion criteria
* Severe claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GTC Frame Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy | 42 |
| BrainLab Thermoplastic Mask Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy | 41 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Dentition problems, could not use frame | 1 | 0 |
| Overall Study | Gag disorder, could not use frame | 4 | 0 |
| Overall Study | Severe kyphosis, could not use mask | 0 | 1 |
| Overall Study | Treatment changed to a single fraction | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | BrainLab Thermoplastic Mask | GTC Frame | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 31 Participants | 61 Participants |
| Age, Continuous | 56.94 years STANDARD_DEVIATION 14.07 | 55.43 years STANDARD_DEVIATION 14.93 | 56.18 years STANDARD_DEVIATION 14.44 |
| Region of Enrollment United States | 41 participants | 42 participants | 83 participants |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 37 |
| serious Total, serious adverse events | 0 / 32 | 0 / 37 |
Outcome results
Primary
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.
Time frame: Measurements taken during SRT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GTC Frame | Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability | 2.00 millimeters | Standard Deviation 1.04 |
| BrainLab Thermoplastic Mask | Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability | 3.17 millimeters | Standard Deviation 1.95 |