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RecruitingInterventional

Pilot Trial of Short Course Radiotherapy for Primary or Secondary CNS Malignancies

NCT ID: NCT07147179Sponsor: Abramson Cancer Center at Penn MedicineLast updated: 2026-05-05

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.

Arms & interventions

  • RadiationShort Course Radiotherapy

    Participants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions).

Outcome measures

Primary

  • 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 year

Secondary

  • Pediatric Quality of Life after Short Course Radiotherapy

    Time frame: 1 year

  • Adolescent Quality of Life after Short Course Radiotherapy

    Time frame: 1 year

  • Overall Survival after Short Course Radiotherapy

    Time frame: 1 year

  • Steroid Usage

    Time frame: 1 year

Eligibility criteria

Sex: AllAge: Up to 21 YearsHealthy 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

Study locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Michael LaRiviere, MD · Principal Investigator
Short Course Radiotherapy | Cancerify