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Recruiting

NCT Number: NCT07147179

Short Course Radiotherapy

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.

Recruiting

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Key information

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Kelly Clark

CONTACT

[email protected]

267-854-5332

Michael LaRiviere, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short Course Radiotherapy

Radiation

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

Primary outcomes

  1. Safety of Short Course Radiotherapy

    Time frame: 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 outcomes

  1. Pediatric Quality of Life after Short Course Radiotherapy

    Time frame: 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

  2. Adolescent Quality of Life after Short Course Radiotherapy

    Time frame: 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

  3. Overall Survival after Short Course Radiotherapy

    Time frame: 1 year

    Time (in weeks) from the last day of radiotherapy to death from any cause

  4. Steroid Usage

    Time frame: 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.

Other outcomes

  1. Rates of brain necrosis

    Time frame: 1 year

    Rates of radiographic and/or pathologic radionecrosis as determined by brain MRI or autopsy findings (if clinically available)

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Clark

CONTACT

[email protected]

267-854-5332

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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