Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Trial
Start Date
10/11/2021
Completion Date
10/15/2027
Summary
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.
Detailed Description
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 is superior to the low-end historical control (Survival rate of 40% at 10 months when calculating from time of enrollment) 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, calculated from date of registration and separately from primary tumor diagnosis date. 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 from date of enrollment to death and from primary tumor diagnosis date to death. 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 computed tomography (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.
Eligibility Criteria
Age Range: 1 years to No maximum
Interventions
Hypofractionated Radiation Therapy
Questionnaire Administration
Magnetic Resonance Imaging
Computed Tomography Scan
Conditions
Locations
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States