Five-day radiation for children and young adults with incurable brain cancers
Pilot Trial of Short Course Radiotherapy for Primary or Secondary CNS Malignancies
This will try a shorter, five-day course of radiation for children and young adults (21 and under) with incurable central nervous system cancers to see if it is safe and improves quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07147179 on ClinicalTrials.gov |
What this trial studies
This is a single-arm prospective pilot testing a short-course palliative radiotherapy regimen delivering 20 Gy in 5 fractions over 5 days to pediatric patients with incurable intracranial malignancies. The regimen shortens treatment compared with standard multi-week daily radiation (typically up to ~3 Gy per day over two weeks or more). Eligibility requires multidisciplinary tumor board consensus of intracranial relapse or metastasis and at least one targetable intracranial lesion, and patients must have a Lansky performance status ≥40. The primary focus is safety with attention to quality-of-life outcomes and feasibility at a single center.
Who should consider this trial
Good fit: Children and young adults age 21 or under with an incurable intracranial malignancy, at least one targetable brain lesion, Lansky performance status ≥40, and a multidisciplinary recommendation for palliative radiation are ideal candidates.
Not a fit: Patients with curable disease, no targetable intracranial lesions, or who are too unwell to tolerate radiation (Lansky <40) are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could shorten palliative treatment time and reduce hospital visits, potentially improving quality of life for pediatric patients.
How similar studies have performed: Short-course palliative radiotherapy regimens have been used in adults and shown feasibility, but this specific five-day approach for pediatric incurable CNS cancers is less well studied and is being tested prospectively.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Michael LaRiviere, MD — University of Pennsylvania
- Study coordinator: Kelly Clark
- Email: Kelly.Clark3@pennmedicine.upenn.edu
- Phone: 267-854-5332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.