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Completed

NCT Number: NCT03841435

Hypofractionated Radiotherapy for Recurrent DIPG

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.

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Key information

Conditions

Recurrent Diffuse Intrinsic Pontine Glioma Brain Diseases Brain Neoplasms Brain Stem Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Diffuse Intrinsic Pontine Glioma Glioma Infratentorial Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypofractionated radiotherapy

Radiation

Radiotherapy Treatment, totaling 15 Gy, will be given in 3 fractions over 2 weeks.

Primary outcomes

  1. Post Radiation Toxicity

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

    RTOG common toxicity criteria grade 0-5

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2019
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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