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Diffuse Midline Glioma, H3 K27M-MutantPhase 2NCT05077735

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

A Phase 2 study testing Hypofractionated Radiation Therapy, Questionnaire Administration and Magnetic Resonance Imaging in people with Diffuse Midline Glioma, H3 K27M-Mutant, run by Mayo Clinic at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Diffuse Midline Glioma, H3 K27M-Mutant
What is being tested?
Hypofractionated Radiation Therapy, Questionnaire Administration and Magnetic Resonance Imaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
2 sitesUnited States
Study dates
11 Oct 2021to 28 May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 If this cannot be completed, patients will be withdrawn from the study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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Stereotactic Biopsy Split-Course Radiation Therapy - Diffuse Midline Glioma (SPORT-DMG)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

  1. 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.

Being tested
Hypofractionated Radiation Therapy, Questionnaire Administration, Magnetic Resonance Imaging, Computed Tomography Scan
Keywords
DIPG, H3K27M, DMG, Diffuse Midline Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated Radiation TherapyRadiation

    Also called Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

    Undergo hypofractionated radiation therapy

  • Questionnaire AdministrationOther

    Ancillary studies

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Computed Tomography ScanProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

Study groups in NCT05077735
Study groupRoleWhat they receive
Treatment (hypofractionated RT)ExperimentalPatients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo MRI and CT scan throughout the study.
Receives: Radiation: Hypofractionated Radiation Therapy; Other: Questionnaire Administration; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) at 10 months

    OS is defined as the time from date of study registration until death due to any cause, assessed at 19 months.

    Measured: At 10 months

Secondary outcomes (7)

  1. Time to second progression

    Defined as the time date of registration or primary tumor diagnosis to the date of radiographic, clinical progression, or death following second course of hypofractionated radiation therapy.

    Measured: Up to 6 years

  2. 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.

    Measured: Baseline up to 6 years

  3. 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).

    Measured: Baseline up to 6 years

  4. 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.

    Measured: Up to 6 years

  5. 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.

    Measured: Up to 6 years

  6. 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.

    Measured: Up to 6 years

  7. 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.

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2021
  2. Study start11 Oct 2021
  3. Primary completion26 Aug 2026
  4. Study completion28 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077735
Sponsor's protocol ID
GMROR2162
Other IDs
21-000069
Status last verified
Sep 2026
First submitted
1 Oct 2021
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypofractionated Radiation Therapy, Questionnaire Administration and Magnetic Resonance Imaging in people with Diffuse Midline Glioma, H3 K27M-Mutant, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) at 10 months (time frame: At 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05077735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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