A Phase 3 interventional study of GTC frame and Thermoplastic facemask in Patients Receiving Fractionated Stereotactic Radiotherapy and for Brain Tumors, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-29.
Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Phase 3, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 83 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 125 studies on the registry; none are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.
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Exclusion Criteria:
Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
Device: GTC frame · Radiation: Stereotactic radiation therapy
Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
Device: Thermoplastic facemask · Radiation: Stereotactic radiation therapy
Also known as: SRT
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
| Milestone | GTC Frame | BrainLab Thermoplastic Mask |
|---|---|---|
| Started | 42 | 41 |
| Completed | 32 | 37 |
| Not completed | 10 | 4 |
| Withdrew: Gag disorder, could not use frame | 4 | 0 |
| Withdrew: Dentition problems, could not use frame | 1 | 0 |
| Withdrew: Withdrawal by subject | 4 | 2 |
| Withdrew: Severe kyphosis, could not use mask | 0 | 1 |
| Withdrew: Treatment changed to a single fraction | 1 | 1 |
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.
| millimeters | GTC Frame | BrainLab Thermoplastic Mask |
|---|---|---|
| Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability | 2.00 ± 1.04 | 3.17 ± 1.95 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GTC Frame | — | 0/32 (0%) | 0/32 (0%) |
| BrainLab Thermoplastic Mask | — | 0/37 (0%) | 0/37 (0%) |
| Age, Categorical(Participants) | GTC Frame | BrainLab Thermoplastic Mask | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 31 | 30 | 61 |
| >=65 years | 11 | 11 | 22 |
| Age, Continuous(years) | GTC Frame | BrainLab Thermoplastic Mask | Total |
|---|---|---|---|
| Mean | 55.43 ± 14.93 | 56.94 ± 14.07 | 56.18 ± 14.44 |
| Sex: Female, Male(Participants) | GTC Frame | BrainLab Thermoplastic Mask | Total |
|---|---|---|---|
| Female | 25 | 22 | 47 |
| Male | 17 | 19 | 36 |
| Region of Enrollment(participants) | GTC Frame | BrainLab Thermoplastic Mask | Total |
|---|---|---|---|
| United States | 42 | 41 | 83 |
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Cancer Center at Thomas Jefferson University