This is a single arm prospective pilot trial determining the safety of short-course radiation therapy in pediatric patients with incurable central nervous system malignancies.
Participants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions) in contrast to the standard treatment of two weeks or more of daily treatments (up to 3 Gray per day). This research study is being conducted to see if delivering a shorter course of radiation therapy is safe and helps quality of life so that it may reduce the required duration of palliative treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Participants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions).
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGSafety of Short Course Radiotherapy
The ability to complete short-course radiotherapy without grade 3 or higher adverse events (AE) that are possibly, probably, or definitely related to radiotherapy during the study period Any individual grade 3 or higher AE that is reported during the study period and deemed possibly, probably, or definitely related to short course radiotherapy will automatically prevent the study from meeting its primary endpoint.
Time frame: 1 year
Pediatric Quality of Life after Short Course Radiotherapy
Trends in composite scores from validated pediatric quality of life instruments, including PedsQLTM (Pediatric Quality of Life Inventory, Children's Hospital and Health Center, San Diego, California), for patients ages 0-18 years, administered at each prespecified time period
Time frame: 1 year
Adolescent Quality of Life after Short Course Radiotherapy
Trends in composite scores from validated adolescent quality of life instruments, including FACT-Br (Functional Assessment of Cancer Therapy-Brain) for patients 18-21 years, administered at each prespecified time period
Time frame: 1 year
Overall Survival after Short Course Radiotherapy
Time (in weeks) from the last day of radiotherapy to death from any cause
Time frame: 1 year
Steroid Usage
A binary endpoint whereby total daily steroid requirement is either increased or not increased compared to the immediately preceding study time point Radiotherapy may result in swelling leading to an increase in neurological symptoms/signs. We will use need for increase in steroid dosing as a surrogate for global neurological function.
Time frame: 1 year
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