Central Nervous System CancerNCT07147179
Short Course Radiotherapy
A study testing Short Course Radiotherapy in people with Central Nervous System Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Central Nervous System Cancer
- What is being tested?
- Short Course Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Radiotherapy for curative intent
- Serious uncontrolled systemic or psychiatric disorders that would interfere with participation in the protocol
- Being planned for proton radiation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kelly Clark, 267-854-5332, Kelly.Clark3@pennmedicine.upenn.edu
Michael LaRiviere, MD
About this study
Official title: Pilot Trial of Short Course Radiotherapy for Primary or Secondary CNS Malignancies
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.
Read the 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
- Being tested
- Short Course Radiotherapy
- Keywords
- Short Course, Radiotherapy
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Course RadiotherapyRadiation
Participants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions).
| Study group | Role | What they receive |
|---|---|---|
| Short Course Radiotherapy | Experimental | Short-course radiation therapy in pediatric patients with incurable central nervous system malignancies Receives: Radiation: Short Course Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
Pediatric Quality of Life after Short Course Radiotherapy
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
Measured: 1 year
Adolescent Quality of Life after Short Course Radiotherapy
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
Measured: 1 year
Overall Survival after Short Course Radiotherapy
Time (in weeks) from the last day of radiotherapy to death from any cause
Measured: 1 year
Steroid Usage
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start2 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael LaRiviere, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147179
- Sponsor's protocol ID
- UPCC 27924
- Other IDs
- 858464
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Short Course Radiotherapy for Primary or Secondary CNS Malignancies
- ClinicalTrials.gov ID
- NCT07147179
- Acronym / sponsor ID
- UPCC 27924
- Conditions
- Central Nervous System Cancer
- Keywords
- Short Course, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short Course Radiotherapy | Experimental | Radiation: Short Course RadiotherapyShort-course radiation therapy in pediatric patients with incurable central nervous system malignancies |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Male or female, aged 21 years or below
- Lansky performance status >= 40
- Has a diagnosis of an incurable malignancy that:
- 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
Key exclusion criteria (3 listed)
- Radiotherapy for curative intent
- Serious uncontrolled systemic or psychiatric disorders that would interfere with participation in the protocol
- Being planned for proton radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Course RadiotherapyParticipants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions). | Radiation | Short Course Radiotherapy |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael LaRiviere, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Course Radiotherapy in people with Central Nervous System Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Clark (267-854-5332, Kelly.Clark3@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Short Course Radiotherapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.