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| ID | Type | Description | Link |
|---|---|---|---|
| 858464 | Other Identifier | University of Pennsylvania Institutional Review Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Course Radiotherapy | Experimental | Short-course radiation therapy in pediatric patients with incurable central nervous system malignancies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Course Radiotherapy | Radiation | Participants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of brain necrosis | Rates of radiographic and/or pathologic radionecrosis as determined by brain MRI or autopsy findings (if clinically available) | 1 year |
Inclusion Criteria:
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
Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Clark | Contact | 267-854-5332 | Kelly.Clark3@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael LaRiviere, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| 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 | 1 year |
| Overall Survival after Short Course Radiotherapy | Time (in weeks) from the last day of radiotherapy to death from any cause | 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. | 1 year |