Short Course Radiotherapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 21 Years
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07147179
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Abramson Cancer Center at Penn Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michael LaRiviere, MD
Principal Investigator Affiliation	University of Pennsylvania
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Central Nervous System Cancer

Additional Details

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.

Arms & Interventions

Arms

Experimental: Short Course Radiotherapy

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

Interventions

Radiation: - Short Course Radiotherapy

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Pennsylvania, Philadelphia 4560349, Pennsylvania 6254927

Status

Address

University of Pennsylvania

Philadelphia 4560349, Pennsylvania 6254927, 19104

Site Contact

Kelly Clark

[email protected]

267-854-5332

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