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

University of Cincinnati1 site in 1 country5 target enrollmentJanuary 31, 2018

ConditionsRecurrent Diffuse Intrinsic Pontine Glioma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Recurrent Diffuse Intrinsic Pontine Glioma
Sponsor: University of Cincinnati
Enrollment: 5
Locations: 1
Primary Endpoint: Post Radiation Toxicity
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 31, 2018

End Date

March 3, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Cincinnati

Responsible Party

Principal Investigator

Luke Pater

Associate Professor of Radiation Oncology, Mediacal Director, West Chester Hospital Radiotherapy

University of Cincinnati

Eligibility Criteria

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
•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.

Outcomes

Primary Outcomes

Post Radiation Toxicity

Time Frame: Through Study Completion, an average of 1 year

RTOG common toxicity criteria grade 0-5

Secondary Outcomes

Progression Free Survival(Through Study Completion, an average of 1 year)
Radiographic Response(1 month)
Change in Quality of Life score(Pre-RT, 2 weeks, 1 month, 3 months and every 3 months there-after post RT)
Overall Survival(Through Study Completion, an average of 1 year)
Steroid Requirement(Through Study Completion, an average of 1 year)