Trial Outcomes & Findings for Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy (NCT NCT00328510)
NCT ID: NCT00328510
Last Updated: 2016-11-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
83 participants
Primary outcome timeframe
Measurements taken during SRT
Results posted on
2016-11-29
Participant Flow
Participant milestones
| Measure |
GTC Frame
Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
|
BrainLab Thermoplastic Mask
Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
|
Overall Study
COMPLETED
|
32
|
37
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
| Measure |
GTC Frame
Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
|
BrainLab Thermoplastic Mask
Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
|
|---|---|---|
|
Overall Study
Gag disorder, could not use frame
|
4
|
0
|
|
Overall Study
Dentition problems, could not use frame
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Severe kyphosis, could not use mask
|
0
|
1
|
|
Overall Study
Treatment changed to a single fraction
|
1
|
1
|
Baseline Characteristics
Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy
Baseline characteristics by cohort
| Measure |
GTC Frame
n=42 Participants
Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
|
BrainLab Thermoplastic Mask
n=41 Participants
Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
41 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
55.43 years
STANDARD_DEVIATION 14.93 • n=5 Participants
|
56.94 years
STANDARD_DEVIATION 14.07 • n=7 Participants
|
56.18 years
STANDARD_DEVIATION 14.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measurements taken during SRTThis 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.
Outcome measures
| Measure |
GTC Frame
n=714 Measurements
Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
|
BrainLab Thermoplastic Mask
n=782 Measurements
Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
|
|---|---|---|
|
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
|
3.17 millimeters
Standard Deviation 1.95
|
Adverse Events
GTC Frame
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BrainLab Thermoplastic Mask
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place