Back to resultsHypofractionated Radiotherapy for Recurrent DIPG
Primary Purpose
Recurrent Diffuse Intrinsic Pontine Glioma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypofractionated Radiotherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Recurrent Diffuse Intrinsic Pontine Glioma
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
- 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.
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypofractionated Radiotherapy
Arm Description
15 Gy given in 3 fractions over 2 weeks
Outcomes
Primary Outcome Measures
Post Radiation Toxicity
RTOG common toxicity criteria grade 0-5
Secondary Outcome Measures
Change in Quality of Life score
Patient reported quality of life via Pediatric Quality of Life Inventory Version 4.0
Radiographic Response
Physician documented change of tumor from pre-RT MRI as compared to 1 month post-RT MRI
Progression Free Survival
Time to clinical, symptomatic or radiographic evidence of disease progression
Overall Survival
Time to patient death
Steroid Requirement
Use of steroids post-RT
Full Information
NCT ID
NCT03841435
First Posted
February 12, 2019
Last Updated
September 12, 2023
Sponsor
University of Cincinnati
Collaborators
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT03841435
Brief Title
Hypofractionated Radiotherapy for Recurrent DIPG
Official Title
Feasibility Study of Hypofractionated Radiotherapy in the Setting of Recurrent Diffuse Intrinsic Pontine Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
March 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Diffuse Intrinsic Pontine Glioma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionated Radiotherapy
Arm Type
Experimental
Arm Description
15 Gy given in 3 fractions over 2 weeks
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiotherapy
Intervention Description
Radiotherapy Treatment, totaling 15 Gy, will be given in 3 fractions over 2 weeks.
Primary Outcome Measure Information:
Title
Post Radiation Toxicity
Description
RTOG common toxicity criteria grade 0-5
Time Frame
Through Study Completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Change in Quality of Life score
Description
Patient reported quality of life via Pediatric Quality of Life Inventory Version 4.0
Time Frame
Pre-RT, 2 weeks, 1 month, 3 months and every 3 months there-after post RT
Title
Radiographic Response
Description
Physician documented change of tumor from pre-RT MRI as compared to 1 month post-RT MRI
Time Frame
1 month
Title
Progression Free Survival
Description
Time to clinical, symptomatic or radiographic evidence of disease progression
Time Frame
Through Study Completion, an average of 1 year
Title
Overall Survival
Description
Time to patient death
Time Frame
Through Study Completion, an average of 1 year
Title
Steroid Requirement
Description
Use of steroids post-RT
Time Frame
Through Study Completion, an average of 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke E Pater, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be kept confidential and will not be shared with other researchers
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Hypofractionated Radiotherapy for Recurrent DIPG
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