Short Course Radiotherapy
ConditionCentral Nervous System Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged 21 years or below
Lansky performance status >= 40
Originates outside the brain but is metastatic to 1 or more sites within the brain, or originates and recurs within the brain. For this diagnosis to be confirmed, there must be multidisciplinary review of up to date imaging at a pediatric tumor board with unanimous consensus of intracranial relapse or metastasis. If the consensus is not unanimous, short-interval repeat imaging with subsequent unanimous consensus would be required in order for this eligibility criteria to be met
Has at least 1 targetable intracranial lesion as seen on imaging
Disqualifiers
Radiotherapy for curative intent
Serious uncontrolled systemic or psychiatric disorders that would interfere with participation in the protocol
Being planned for proton radiation
Trial design
Design model
Single group
Treatments tested in this trial
Short Course Radiotherapy
RadiationParticipants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions).
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Short Course RadiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety 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 yearSecondary outcomes
1
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 year2
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 year3
Overall Survival after Short Course Radiotherapy
Time (in weeks) from the last day of radiotherapy to death from any cause
Time frame
1 year4
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 yearOther outcomes
1
Rates of brain necrosis
Rates of radiographic and/or pathologic radionecrosis as determined by brain MRI or autopsy findings (if clinically available)
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov