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

ConditionDiffuse Midline Glioma, H3 K27M-Mutant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 If this cannot be completed, patients will be withdrawn from the study

Disqualifiers

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)

Pregnant women

Trial design

Design model

Single group

Treatments tested in this trial

  • Hypofractionated Radiation Therapy

    Radiation

    Undergo hypofractionated radiation therapy

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Positron Emission Tomography and Computed Tomography Scan

    Procedure/Surgery

    Undergo PET-CT scan

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: Treatment (hypofractionated RT)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Time to progression

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

Time frame
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

1

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.

Time frame
Baseline up to 3 years
2

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).

Time frame
Baseline up to 3 years
3

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.

Time frame
Up to 3 years
4

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.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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