Hypofractionated Radiotherapy for Recurrent DIPG

NCT03841435 | Completed DMC

• 1 other identifier: 2017-2183
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Diffuse Intrinsic Pontine Glioma

Outcome Measures

Primary Outcomes (1)

• Post Radiation Toxicity

  RTOG common toxicity criteria grade 0-5

  Through Study Completion, an average of 1 year

Secondary Outcomes (5)

• Change in Quality of Life score

  Pre-RT, 2 weeks, 1 month, 3 months and every 3 months there-after post RT

• Radiographic Response

  1 month

• Progression Free Survival

  Through Study Completion, an average of 1 year

• Overall Survival

  Through Study Completion, an average of 1 year

• Steroid Requirement

  Through Study Completion, an average of 1 year

Study Arms (1)

Hypofractionated Radiotherapy

EXPERIMENTAL

15 Gy given in 3 fractions over 2 weeks

Radiation: Hypofractionated Radiotherapy

Interventions

Hypofractionated Radiotherapy RADIATION

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

Hypofractionated Radiotherapy

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 \~)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (17)

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  BACKGROUND

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MeSH Terms

Conditions

Diffuse Intrinsic Pontine Glioma

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Glioma; 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

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Luke E Pater, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology, Mediacal Director, West Chester Hospital Radiotherapy

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: January 31, 2018
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)