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

NCT05077735 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: GMROR2162NCI-2021-1001021-000069
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diffuse Midline Glioma, H3 K27M-Mutant

Keywords

DIPG; H3K27M; DMG; Diffuse Midline Glioma

Outcome Measures

Primary Outcomes (1)

• Time to progression

  The Wilcoxon Signed-Rank Tests for Non-Inferiority was utilized from PASS software for this design.

  From date of diagnosis to the date of radiographic or clinical progression following second course of hypofractionated radiation therapy, assessed up to 3 years

Secondary Outcomes (6)

• Quality of Life Measurement - PedsQL (children under 18)

  Baseline up to 3 years

• Quality of Life Measurement - NFBrSI-24

  Baseline up to 3 years

• Progression free survival

  Up to 3 years

• FACT-General Family/Caregiver Questionnaire (FACT-G)

  Up to 3 years

• Overall survival

  Up to 3 years

Study Arms (1)

Treatment (hypofractionated RT)

EXPERIMENTAL

Patients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo MRI and PET-CT scan throughout the study.

Radiation: Hypofractionated Radiation Therapy; Other: Questionnaire Administration; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography and Computed Tomography Scan

Interventions

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

Treatment (hypofractionated RT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (hypofractionated RT)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MRI, MR Imaging, MRI Scan, MRIs, NMR Imaging, NMRI, nuclear magnetic resonance imaging, sMRI, Structural MRI

Treatment (hypofractionated RT)

Positron Emission Tomography and Computed Tomography Scan PROCEDURE

Undergo PET-CT scan

Also known as: PET-CT Scan, PET/CT SCAN, Positron Emission Tomography/Computed Tomography

Treatment (hypofractionated RT)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Radiation Dose Hypofractionation; Radiation; Magnetic Resonance Spectroscopy; X-Rays

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Physical Phenomena; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Radiation, Ionizing

Study Officials

• Roman O. Kowalchuk, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: October 11, 2021
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (2)