Hypofractionated Radiotherapy for Recurrent DIPG

Study Overview
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Brief Summary
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This study evaluates the feasibility of hypofractionated radiotherapy (RT) in the palliative treatment of recurrent diffuse intrinsic pontine glioma (DIPG). Participants will receive 15 Gy in 3 fractions as opposed to the standard 20 Gy in 10 fractions.

Official Title
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Feasibility Study of Hypofractionated Radiotherapy in the Setting of Recurrent Diffuse Intrinsic Pontine Glioma

Conditions
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Recurrent Diffuse Intrinsic Pontine Glioma

Intervention / Treatment
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* Radiation: Hypofractionated Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be ≤30 years of age Patients must have a diagnosis of progressive DIPG. Received prior IMRT based definitive radiotherapy to a dose of ≥54 Gy. The patient and or parent/legal guardian must be physically and mentally capable of signing the consent form of their own volition. Steroids dosage must be unchanged for 5 days. No Bevacizumab within 21 days (Half-life 11 days  ) Exclusion Criteria: Patients with incomplete medical records Patients with prior history of reirradiation for DIPG Life expectancy < or equal to 1 month Pregnant women Age >30 Prisoners Concurrent systemic therapy at the time of reirradiation Physically or mentally incapable of signing the consent form of their own volition < 6 mos time interval between completion of initial RT to start of reRT.

Ages Eligible for Study
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Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated Radiotherapy<br>15 Gy given in 3 fractions over 2 weeks | Radiation: Hypofractionated Radiotherapy<br>* Radiotherapy Treatment, totaling 15 Gy, will be given in 3 fractions over 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Radiation Toxicity | RTOG common toxicity criteria grade 0-5 | Through Study Completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life score | Patient reported quality of life via Pediatric Quality of Life Inventory Version 4.0 | Pre-RT, 2 weeks, 1 month, 3 months and every 3 months there-after post RT | 
| Radiographic Response | Physician documented change of tumor from pre-RT MRI as compared to 1 month post-RT MRI | 1 month | 
| Progression Free Survival | Time to clinical, symptomatic or radiographic evidence of disease progression | Through Study Completion, an average of 1 year | 
| Overall Survival | Time to patient death | Through Study Completion, an average of 1 year | 
| Steroid Requirement | Use of steroids post-RT | Through Study Completion, an average of 1 year |