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

Diffuse Midline Glioma, H3 K27M-Mutant Clinical Trial

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

Status Recruiting

Clinical 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. This may determine if there is a difference in the outcome of the treatment, and most importantly, the patients' quality of life.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To estimate the time to progression after the second hypofractionated radiation course of 25 Gy in 10 fractions in patients with diffuse midline glioma of the pons, calculated from date of diagnosis.

SECONDARY OBJECTIVES:

I. To evaluate the quality of life outcomes for patients with diffuse midline gliomas of the pons.

II. To estimate progression free survival intervals for patients after each hypofractionated radiation treatment course.

III. 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.

IV. To estimate the overall survival for patients with diffuse midline gliomas of the pons treated with planned multi-course hypofractionated radiation courses.

V. 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 achieve progression undergo up to 2 retreatment courses. Patients undergo magnetic resonance imaging (MRI) and positron emission tomography- computed tomography (PET-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. ;

Related Conditions & MeSH terms

• Diffuse Midline Glioma, H3 K27M-Mutant
• Glioma

• NCT number: NCT05077735
• Study type: Interventional
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies@mayo.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: October 11, 2021
• Completion date: October 15, 2027