Stereotactic Biopsy Split-Course Radiation Therapy - Diffuse Midline Glioma (SPORT-DMG)
Mayo Clinic
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.
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 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…
Eligibility
- Age range
- 1+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>= 1 year(s) old (no maximum age) * Radiologic appearance of diffuse midline glioma of the pons, including diffuse infiltration of \>= 50% of the pons on MRI, with or without extension to the midbrain and/or medulla oblongata with at least 1 of the 3 brainstem symptoms (cranial nerve deficit, long tract sign, or cerebellar sign) * If all features of this clinicoradiologic criteria are met, then patients can continue on protocol with or without a biopsy * If all features of this clinicoradiologic criteria are not met, patients must receive a brainstem lesion bio…
Interventions
- RadiationHypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePositron Emission Tomography and Computed Tomography Scan
Undergo PET-CT scan
Locations (2)
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- Mayo Clinic in RochesterRochester, Minnesota