Short Course Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Short Course Radiotherapy.
- Who it may be relevant to
- Registry conditions: Central Nervous System Cancer. Basic parameters: up to 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Trial of Short Course Radiotherapy for Primary or Secondary CNS Malignancies
Overview
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.
Interventions
- Radiation Short Course Radiotherapy
Participants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions).
Primary outcome measures
- Safety of Short Course Radiotherapy [Time frame: 1 year]
Secondary outcome measures (4)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07147179 · UPCC 27924 · 858464