University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT07147179
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.
Interested in participating?
Request InfoUp to 21 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions).
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.
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
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
Time frame: 1 year
Time (in weeks) from the last day of radiotherapy to death from any cause
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.
Time frame: 1 year
Rates of radiographic and/or pathologic radionecrosis as determined by brain MRI or autopsy findings (if clinically available)
Contact information is provided by the study sponsor or research team.
Abramson Cancer Center at Penn Medicine
Other
Pilot Trial of Short Course Radiotherapy for Primary or Secondary CNS Malignancies
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.
Published trials that share one or more normalized conditions with this study.
NCT02012699
Abdominal Neoplasms, Adenoma
Greenwood Village, Colorado, United States
View Trial DetailsNCT07462507
Astrocytoma, Brain Diseases
St Louis, Missouri, United States
View Trial DetailsNCT05219149
Central Nervous System Cancer, Central Nervous System Neoplasms
Aurora, Colorado, United States
View Trial DetailsNCT04992013
Central Nervous System Cancer, Central Nervous System Neoplasms
Boston, Massachusetts, United States
View Trial Details