Short Course Radiotherapy

Not Applicable

Not yet recruiting

• Conditions: Central Nervous System Cancer

• Registration Number: NCT07147179
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-27
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-12-01
• Primary Completion: 2027-03
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States