Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-31 @ 9:15 PM
Study NCT ID:
NCT05077735
Status:
RECRUITING
Last Update Posted:
2025-01-03
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Study
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Stereotactic Biopsy Split-Course Radiation Therapy - Diffuse Midline Glioma (SPORT-DMG)
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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 midline glioma of the pons, calculated from date of diagnosis.
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.
V. To estimate the overall survival for patients with diffuse midline gliomas of the pons treated with planned multi-course hypofractionated radiation courses.
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 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.
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 midline glioma of the pons, calculated from date of diagnosis.
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.
V. To estimate the overall survival for patients with diffuse midline gliomas of the pons treated with planned multi-course hypofractionated radiation courses.
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 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: