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Hypofractionated Radiotherapy for Recurrent DIPG

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03841435
Recruitment Status : Enrolling by invitation
First Posted : February 15, 2019
Last Update Posted : July 2, 2021
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Luke Pater, University of Cincinnati

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Diffuse Intrinsic Pontine Glioma Radiation: Hypofractionated Radiotherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility Study of Hypofractionated Radiotherapy in the Setting of Recurrent Diffuse Intrinsic Pontine Glioma
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Post Radiation Toxicity [ Time Frame: Through Study Completion, an average of 1 year ]
    RTOG common toxicity criteria grade 0-5


Secondary Outcome Measures :
  1. 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

  2. Radiographic Response [ Time Frame: 1 month ]
    Physician documented change of tumor from pre-RT MRI as compared to 1 month post-RT MRI

  3. Progression Free Survival [ Time Frame: Through Study Completion, an average of 1 year ]
    Time to clinical, symptomatic or radiographic evidence of disease progression

  4. Overall Survival [ Time Frame: Through Study Completion, an average of 1 year ]
    Time to patient death

  5. Steroid Requirement [ Time Frame: Through Study Completion, an average of 1 year ]
    Use of steroids post-RT


Eligibility Criteria
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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841435


Locations
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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Luke E Pater, MD University of Cincinnati
More Information
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Publications:
Lassaletta A, Bartels U, Strother D, et al. Hg-57re-irradiation in patients with diffuse intrinsic pontine gliomas, an update on the canadian experience. Neuro-Oncology 2016;18:iii60-iii61.

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Responsible Party: Luke Pater, Associate Professor of Radiation Oncology, Mediacal Director, West Chester Hospital Radiotherapy, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03841435    
Other Study ID Numbers: 2017-2183
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will be kept confidential and will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Diffuse Intrinsic Pontine Glioma
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Brain Stem Neoplasms
Infratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases