SPORT-DMG Trial: Radiation Therapy for Diffuse Midline Glioma

This study, called SPORT-DMG, is looking at a new way to give radiation therapy for diffuse midline glioma (a type of brain tumor). Instead of the usual 6 weeks of radiation, this study will give radiation over 2 weeks. Researchers want to see if this shorter treatment, called hypofractionated radiation therapy, can improve how long patients live and their quality of life. They will compare the 10-month survival rate of this new approach to the standard treatment. The study is for people aged 1 year and older with diffuse midline glioma that has a specific genetic change (H3 K27M-Mutant). To see if the treatment is working, you would have MRI and CT scans, and fill out questionnaires. The study is currently recruiting 32 participants.

Study design
This is a single-arm interventional study with a planned enrollment of 32 participants. It aims to compare the outcomes of a new radiation schedule to historical data.
What's involved
Participants will undergo hypofractionated radiation therapy over 10 fractions. They will also have MRI and CT scans, and complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track overall survival for up to 6 years, and time to progression at 10 months.

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NCT05077735

Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Trial

Recruiting
PHASE2Ages 1+InterventionalTreatment
Mayo Clinic
~32 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Hypofractionated Radiation TherapyQuestionnaire AdministrationMagnetic Resonance ImagingComputed Tomography Scan

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to progression
Measured over At 10 months
+1 more outcome measured
Diffuse Midline Glioma, H3 K27M-Mutant
2 sites across 2 states
Arizona1
Minnesota1
  • Roman O. Kowalchuk, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

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Eligibility criteria

Inclusion

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 biopsy to be treated on protocol. If this cannot be completed, patients will be withdrawn from the study
If biopsy has already been completed at an outside institution, the outside pathology report will be reviewed ahead of trial enrollment. The pathology specimen will then be sent to Mayo Clinic for further review, but will not delay study enrollment
Able to undergo MRI Brain
Negative urine pregnancy test completed =\< 7 days prior to registration, for women of childbearing potential only
Primary language of English or Spanish for patients and their caregiver
Patient or caregiver willing and able to provide written informed consent
Caregiver able to complete questionnaires by themselves or with assistance
Willing to return to enrolling institution for follow-up during the active monitoring phase of the study

Exclusion

Any patient who has received previous radiation to the brain
Any patient who has received previous chemotherapy
Any patient with a diagnosis of neurofibromatosis type 1 or 2 (NF1 or NF2)
Any of the following:
Pregnant women
Nursing women
Women of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Other active malignancy =\< 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix
NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
Patients \> 16 years with an Eastern Cooperative Oncology Group (ECOG) score \>= 4 and patients =\< 16 years with a Lansky play scale =\< 20
NOTE: All novel therapeutic interventions, including but not limited to dordaviprone, are allowed for patients who enroll on the clinical trial
  • Time to progressionAt 10 months

    Defined as the time from date of diagnosis to the date of radiographic or clinical progression following second course of hypofractionated radiation therapy.

  • Overall Survival (OS) at 10 monthsUp to 6 years

    OS is defined as the time from date of study registration until death due to any cause.