Recurrent Diffuse Intrinsic Pontine Glioma
Conditions
Brief summary
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.
Interventions
RADIATIONHypofractionated Radiotherapy
Radiotherapy Treatment, totaling 15 Gy, will be given in 3 fractions over 2 weeks.
Sponsors
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must be ≤30 years of age 2. Patients must have a diagnosis of progressive DIPG. 3. Received prior IMRT based definitive radiotherapy to a dose of ≥54 Gy. 4. The patient and or parent/legal guardian must be physically and mentally capable of signing the consent form of their own volition. 5. Steroids dosage must be unchanged for 5 days. 6. No Bevacizumab within 21 days (Half-life 11 days \ )
Exclusion criteria
1. Patients with incomplete medical records 2. Patients with prior history of reirradiation for DIPG 3. Life expectancy \< or equal to 1 month 4. Pregnant women 5. Age \>30 6. Prisoners 7. Concurrent systemic therapy at the time of reirradiation 8. Physically or mentally incapable of signing the consent form of their own volition 9. \< 6 mos time interval between completion of initial RT to start of reRT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Radiation Toxicity | Through Study Completion, an average of 1 year | RTOG common toxicity criteria grade 0-5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life score | Pre-RT, 2 weeks, 1 month, 3 months and every 3 months there-after post RT | Patient reported quality of life via Pediatric Quality of Life Inventory Version 4.0 |
| Radiographic Response | 1 month | Physician documented change of tumor from pre-RT MRI as compared to 1 month post-RT MRI |
| Progression Free Survival | Through Study Completion, an average of 1 year | Time to clinical, symptomatic or radiographic evidence of disease progression |
| Overall Survival | Through Study Completion, an average of 1 year | Time to patient death |
| Steroid Requirement | Through Study Completion, an average of 1 year | Use of steroids post-RT |
Countries
United States
Outcome results
None listed