Hypofractionated Radiotherapy for Recurrent DIPG

September 12, 2023 updated by: Luke Pater, University of Cincinnati

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Radiation Toxicity
Time Frame: Through Study Completion, an average of 1 year
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
Time Frame: 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
Pre-RT, 2 weeks, 1 month, 3 months and every 3 months there-after post RT
Radiographic Response
Time Frame: 1 month
Physician documented change of tumor from pre-RT MRI as compared to 1 month post-RT MRI
1 month
Progression Free Survival
Time Frame: Through Study Completion, an average of 1 year
Time to clinical, symptomatic or radiographic evidence of disease progression
Through Study Completion, an average of 1 year
Overall Survival
Time Frame: Through Study Completion, an average of 1 year
Time to patient death
Through Study Completion, an average of 1 year
Steroid Requirement
Time Frame: Through Study Completion, an average of 1 year
Use of steroids post-RT
Through Study Completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Luke E Pater, MD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2018

Primary Completion (Actual)

March 3, 2023

Study Completion (Actual)

March 3, 2023

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-2183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will be kept confidential and will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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