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Radiation Therapy

Hypofractionated Radiation Therapy for Brain Cancer

Phase 2

Recruiting

Led By Danielle A Cunningham

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial studies a new way of delivering radiation to patients with diffuse midline gliomas, which may improve the outcome of the treatment and the patients' quality of life.

Who is the study for?

This trial is for patients with a brain tumor called diffuse midline glioma. Eligible participants include those who have had or can undergo a biopsy, are able to give consent, complete questionnaires in English or Spanish, and return for follow-up. It's not for pregnant women, nursing mothers, people with severe diseases that could affect the study results, or those who've had prior brain radiation or chemotherapy.Check my eligibility

What is being tested?

The SPORT-DMG Study tests if giving hypofractionated radiation therapy over 2 weeks instead of the usual 6 improves clinical outcomes and quality of life in diffuse midline glioma patients. The treatment's impact on daily living will be assessed through questionnaires.See study design

What are the potential side effects?

While specific side effects aren't listed here, hypofractionated radiation therapy may cause fatigue, skin irritation at the treatment site, headaches, nausea and potential cognitive changes depending on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My MRI shows a tumor in the middle of my brain stem affecting over half of the pons area, and I have symptoms like nerve issues, movement problems, or coordination difficulties.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to progression

Secondary outcome measures

FACT-General Family/Caregiver Questionnaire

Incidence of adverse events

Overall survival

+2 more

Side effects data

From 2022 Phase 2 trial • 107 Patients • NCT03324802

80%

Dermatitis radiation

54%

Skin hyperpigmentation

48%

Pain

35%

Lymphedema

22%

Superficial soft tissue fibrosis

Skin hypopigmentation

Edema limbs

Device related infection

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1 (Radiation Therapy, 15 Fractions)

Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (hypofractionated RT)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography and Computed Tomography Scan

2015

N/A

~20

Hypofractionated Radiation Therapy

2016

Completed Phase 2

~130

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,767,020 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,836 Total Patients Enrolled

Danielle A CunninghamPrincipal InvestigatorMayo Clinic in Rochester

Media Library

$Hypofractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05077735 — Phase 2$

$Diffuse Midline Glioma Research Study Groups: Treatment (hypofractionated RT)$

$Diffuse Midline Glioma Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT05077735 — Phase 2$

$Hypofractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05077735 — Phase 2$

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still accepting participants?

"This clinical trial is currently seeking participants, as per the information found on clinicaltrials.gov. The study first went live on October 6th 2021 and was most recently updated in January of 2022."

Answered by AI

How many participants are enrolled in the current medical experiment?

"Yes, clinicaltrials.gov attests to this medical study's ongoing recruitment process that began on October 6th 2021 and was last updated on January 31st 2022. A total of 18 patients will be sought from a single location."

Answered by AI

Has the FDA sanctioned Hypofractionated Radiation Therapy?

"Hypofractionated Radiation Therapy's safety was evaluated at a score of 2 as, while there is limited data to support its security, there are no studies yet that assess the efficacy of this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05077735.