Short Course Radiotherapy

Abramson Cancer Center at Penn Medicine

Status: Not yet enrolling

Conditions: Central Nervous System Cancer

Treatments: Radiation: Short Course Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07147179

UPCC 27924

858464 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Short Course Radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: Short Course Radiotherapy