Central Nervous System Cancer
Conditions
Keywords
Short Course, Radiotherapy
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONShort Course Radiotherapy
Participants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions).
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 21 years or below * Lansky performance status \>= 40 * Has a diagnosis of an incurable malignancy that: * 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 * Has a multidisciplinary consensus recommendation for palliative intent radiation * Consents to the study or has caregiver who is able to provide signed and dated informed consent. For subjects under the age of 18, a signed and dated assent form as able. * Patients who had prior radiation in planned treatment area are also eligible to enter the trial * Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
* Radiotherapy for curative intent * Serious uncontrolled systemic or psychiatric disorders that would interfere with participation in the protocol * Being planned for proton radiation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Short Course Radiotherapy | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Quality of Life after Short Course Radiotherapy | 1 year | 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 |
| Adolescent Quality of Life after Short Course Radiotherapy | 1 year | 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 |
| Overall Survival after Short Course Radiotherapy | 1 year | Time (in weeks) from the last day of radiotherapy to death from any cause |
| Steroid Usage | 1 year | 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. |
Countries
United States
Contacts
CONTACTKelly Clark
PRINCIPAL_INVESTIGATORMichael LaRiviere, MD
University of Pennsylvania
Outcome results
None listed