Hypofractionated Radiotherapy for Recurrent DIPG

Not Applicable

Completed

• Conditions: Recurrent Diffuse Intrinsic Pontine Glioma
• Interventions: Radiation: Hypofractionated Radiotherapy

• Registration Number: NCT03841435
• Lead Sponsor: University of Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-31
• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated Radiotherapy	Hypofractionated Radiotherapy	15 Gy given in 3 fractions over 2 weeks

Primary Outcome Measures

Name	Time	Method
Post Radiation Toxicity	Through Study Completion, an average of 1 year	RTOG common toxicity criteria grade 0-5

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	Through Study Completion, an average of 1 year	Time to clinical, symptomatic or radiographic evidence of disease progression
Radiographic Response	1 month	Physician documented change of tumor from pre-RT MRI as compared to 1 month post-RT MRI
Change in Quality of Life score	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
Overall Survival	Through Study Completion, an average of 1 year	Time to patient death
Steroid Requirement	Through Study Completion, an average of 1 year	Use of steroids post-RT

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States