NCT07147179

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

August 27, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

April 2, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

August 27, 2025

Last Update Submit

April 29, 2026

Conditions

Central Nervous System Cancer

Keywords

Short CourseRadiotherapy

Outcome Measures

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.

    1 year

Secondary Outcomes (4)

  • Pediatric Quality of Life after Short Course Radiotherapy

    1 year

  • Adolescent Quality of Life after Short Course Radiotherapy

    1 year

  • Overall Survival after Short Course Radiotherapy

    1 year

  • Steroid Usage

    1 year

Other Outcomes (1)

  • Rates of brain necrosis

    1 year

Study Arms (1)

Short Course Radiotherapy

EXPERIMENTAL

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

Radiation: Short Course Radiotherapy

Interventions

Short Course RadiotherapyRADIATION

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

Short Course Radiotherapy

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Radiotherapy for curative intent
  • Serious uncontrolled systemic or psychiatric disorders that would interfere with participation in the protocol
  • Being planned for proton radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Study Officials

  • Michael LaRiviere, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Clark

CONTACT

267-854-5332Kelly.Clark3@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2025

First Posted

August 29, 2025

Study Start

April 2, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)