This phase II trial studies the clinical outcomes of hypofractionated radiation therapy in patients with diffuse midline gliomas. This study aims to change the way radiation is delivered, from giving 6 weeks of radiation all at once to giving 2 weeks of radiation. This may determine if there is a difference in the outcome of the treatment, and most importantly, the patients' quality of life.
PRIMARY OBJECTIVE: I. To determine that 10-month overall survival (OS) rate for the hypofractionated radiation course of 25 Gy in 10 fractions in patients with diffuse midline glioma of the pons isn't inferior to the historical control (survival rate of 50% at 10 months) based on the current standard of care (54 GY in 30 fractions). SECONDARY OBJECTIVES: I. To evaluate the quality of life outcomes for patients with diffuse midline gliomas of the pons. II. To estimate the time to progression after the second hypofractionated radiation course of 25 Gy in 10 fractions in patients with diffuse midline glioma of the pons, calculated from date of diagnosis. III. To estimate progression free survival intervals for patients after each hypofractionated radiation treatment course. IV. To evaluate the quality of life outcomes for parents of patients =\< 18 years with the Functional Assessment of Cancer Therapy General (FACT-G) Family/Caregiver Questionnaire. V. To estimate the overall survival for patients with diffuse midline gliomas of the pons treated with planned multi-course hypofractionated radiation courses. VI. To report toxicities associated with hypofractionated, planned, multi-course radiation treatment for diffuse midline glioma of the pons. OUTLINE: Patients undergo hypofractionated radiation therapy (RT) over 10 fractions. Patients who experience progression undergo up to 2 retreatment courses. Patients undergo magnetic resonance imaging (MRI) and positron emission tomography- computed tomography (PET-CT) scan throughout the study. After completion of study treatment, patients are followed up at 1 month, every 2 months for year 1, every 3 months for year 2, then every 6 months for year 3.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Undergo hypofractionated radiation therapy
Ancillary studies
Undergo MRI
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
RECRUITINGMayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGTime to progression
The Wilcoxon Signed-Rank Tests for Non-Inferiority was utilized from PASS software for this design.
Time frame: From date of diagnosis to the date of radiographic or clinical progression following second course of hypofractionated radiation therapy, assessed up to 3 years
Quality of Life Measurement - PedsQL (children under 18)
Results from Pediatric Quality of Life Inventory (PedsQL) Brain Tumor Module will be used to evaluate the quality of life outcomes in patients up to 18 years old. PedsQL™ assessments include 23 items answered on aLikert response scale (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem) for each item.
Time frame: Baseline up to 3 years
Quality of Life Measurement - NFBrSI-24
The National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT)-Brain Symptom Index-24 (NFBrSI-24) will be used in patients more than 18 years old. Changes in raw score from baseline to each time-point will be assessed in each of the physical and mental health domains. The NFBrSI-24 consists of 24 questions assessing symptoms over the past 7 days. Items are scored on a 5-point Likert type scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much).
Time frame: Baseline up to 3 years
Progression free survival
The average progression free survival interval after each course of RT will be reported in months. Progression free survival is defined as the time from registration date to the earliest date of documentation of progression after each course of radiation therapy (RT) or death due to any cause.
Time frame: Up to 3 years
FACT-General Family/Caregiver Questionnaire (FACT-G)
Changes in raw score from baseline to each time-point will be assessed in each of the physical and mental health domains. The FACT-G contains 27 questions within 4 subscale domains \[Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being\] related to health-related quality of life (QOL) in the past 7 days, with higher scoring indicating better QOL.
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Undergo PET-CT scan
Time frame: Up to 3 years
Overall survival
Overall survival is defined as the time from registration date to death due to any cause. Patients alive at the date of last contact will be censored.
Time frame: Up to 3 years
Incidence of adverse events
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Time frame: Up to 3 years