• Incidence of adverse events [ Time Frame: Up to 6 weeks ]
  Graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety will be summarized with standard summary statistics by adverse event (AE), grade, relation, etc. using the CTCAE 5.0. All summaries will be calculated for each control and experimental forehead and ears.
• StrataXRT as a preventative agent for radiation-associated dermatitis [ Time Frame: Up to 6 weeks ]
  To estimate the efficacy of StrataXRT among pediatric patients.

• Incidence of adverse events [ Time Frame: Up to 6 weeks ]
  Graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety will be summarized with standard summary statistics by adverse event (AE), grade, relation, etc. using the CTCAE 5.0. All summaries will calculated for each control and experimental forehead and ears.
• StrataXRT as a preventative agent for radiation-associated dermatitis [ Time Frame: Up to 6 weeks ]
  Efficacy will be defined using the Radiation Therapy Oncology Group/European Organization for the Research and Treatment of Cancer (RTOG/EROTC) for both treatment and placebo groups. The RTOG/EROTC scales will be summarized by control and experimental ears at each time point (baseline, 5 weekly treatment visits, and at treatment completion visit [last day of radiation therapy]). Will estimate the treatment effect using generalized linear mixed models (GLMM). The primary efficacy measure will be the maximum grade observed from the Radiation Therapy Oncology Group (RTOG) throughout the six weeks of therapy. As grade 3 and 4 are clinically meaningful. The dependent variable will be observing a maximum grade of 3 and above (yes/no) and independent variable of treatment (StrataXRT vs. Placebo). The GLMM will allow random intercepts and treatment effects to take into account the within subject correlation and paired nature of the data (left ear vs. right ear treatment assignment).

• Dosing of StrataXRT [ Time Frame: Up to 6 weeks ]
• Parent-reported symptom experience [ Time Frame: Up to 6 weeks ]
  Will be measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The RISRAS Radiation-Induced Skin Reaction Assessment Scale will be summarized by control and experimental ears at each time point (baseline, 5 weekly treatment visits, and at treatment completion visit [last day of radiation therapy]).
• Compliance [ Time Frame: Up to 6 weeks ]
  As documented in a study log by participants.

• Dosing of StrataXRT [ Time Frame: Up to 6 weeks ]
• Parent-reported symptom experience [ Time Frame: Up to 6 weeks ]
  As measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The RISRAS scale will be summarized by control and experimental ears at each time point (baseline, 5 weekly treatment visits, and at treatment completion visit [last day of radiation therapy]).
• Compliance [ Time Frame: Up to 6 weeks ]
  As documented in a study log by participants.

PRIMARY OBJECTIVES:

I. To estimate the safety (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) of StrataXRT and placebo by assessing gel-associated toxicities among pediatric patients, aged 2-17 undergoing proton cerebrospinal irradiation (CSI) for central nervous system (CNS) tumors.

II. To estimate the efficacy of StrataXRT as a preventative agent for radiation-associated dermatitis among pediatric patients, aged 2-17 undergoing proton CSI for CNS tumors.

SECONDARY OBJECTIVES:

I. To explore the relationship between dosing and the efficacy of StrataXRT. II. To explore the relationship between the use of StrataXRT and parent-reported symptom experience, as measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS).

III. To explore compliance with the application of treatment as documented in a study log by participants.

OUTLINE:

Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear twice daily (BID) until the last day of radiation therapy.

• Central Nervous System Sarcoma
• Ependymoma
• Glioma
• Malignant Intracranial Germ Cell Tumor
• Medulloblastoma
• Pineoblastoma
• Primary Central Nervous System Neoplasm

• Other: Placebo Administration
  Applied topically
  Other Names:

  • placebo
  • placebo therapy
  • PLCB
  • sham therapy
• Other: Questionnaire Administration
  Ancillary studies
• Drug: Wound Dressing Material
  Applied StrataXRT topically
  Other Name: Wound Dressing

Inclusion Criteria:

• Pediatric patients between the ages of 2 years old and 17 years old
• Patients diagnosed with primary CNS tumors including medulloblastoma, pineoblastoma, ependymoma, intracranial germ cell, glioma or intracranial sarcoma who will be starting proton CSI
• Patients planned to receive at least 20 Gy CSI at 1.8 - 2.0 Gy per fraction
• Patients with an identified adult (aged 18 years or older caregiver)(familial or other) who consents to apply the StrataXRT and placebo twice a day for the duration of the study and complete the study instruments
• Informed consent by parents or legal guardian; consent documents will be translated with non-English speaking participants

Exclusion Criteria:

• Patients who have already started proton CSI treatment
• Patients receiving > 10 fractions photon therapy
• Patients with pre-existing dermal scarring, as determined by a clinical member of the study staff
• Patients who only have a primary caregiver who is a minor (e.g. mother under the age of 18)
• Patients planned to receive less than 20 Gy CSI at 1.8-2.0 Gy per fraction