Short Course Radiotherapy

NCT ID: NCT07147179

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-03-31

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.

Conditions

Central Nervous System Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short Course Radiotherapy

Short-course radiation therapy in pediatric patients with incurable central nervous system malignancies

Group Type: EXPERIMENTAL

Short Course Radiotherapy

Intervention Type: RADIATION

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

Interventions

Short Course Radiotherapy

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael LaRiviere, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Central Contacts

Kelly Clark

Role: CONTACT

Kelly.Clark3@pennmedicine.upenn.edu

267-854-5332

Facility Contacts

Kelly Clark

Role: primary

Kelly.Clark3@pennmedicine.upenn.edu

267-854-5332

Other Identifiers

UPCC 27924

Identifier Type: -

Identifier Source: org_study_id

858464

Identifier Type: OTHER

Identifier Source: secondary_id