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Radiation Therapy

Genu-Sparing Whole Brain Radiation for Brain Cancer

N/A
Recruiting
Led By Kristin Redmond, MD, MPH
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site
Karnofsky Performance Status (KPS) score ≥70
Must not have
Patient has brain metastases in the genu
Prior whole brain radiation therapy (WBRT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 6 and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a certain type of brain radiation can help preserve brain function in patients with brain cancer.

Who is the study for?
This trial is for adults over 18 with brain metastases who can consent to treatment, have a performance status score of ≥70, and are expected to live at least 6 more months. They must be able to use contraception and have not had whole brain radiation before. Non-English speakers, those with serious illnesses preventing protocol adherence or MRI contraindications, are excluded.
What is being tested?
The study tests genu-sparing whole brain radiation therapy (WBRT) aimed at preserving cognitive and neuropsychiatric functions in patients with brain metastases. It's designed for those who've possibly undergone prior stereotactic radiosurgery but haven't received WBRT.
What are the potential side effects?
While the trial focuses on sparing the genu to preserve function, side effects may include typical radiation-related issues such as fatigue, hair loss, skin irritation at the treated area, headaches, nausea and potential cognitive changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer diagnosis is confirmed by lab tests on tissue or fluid samples.
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I am able to care for myself but may not be able to do active work.
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I am scheduled for whole brain radiation therapy for brain metastases.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer that has spread to a specific part of my brain.
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I have had whole brain radiation therapy before.
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My health limits my ability to care for myself.
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My memory and thinking skills test score is below 24.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of change of cognitive function
Secondary study objectives
Rate of change in QoL
Rate of change in other frontally-mediated functions
Rate of change of cognition
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Corpus Callosum Genu-Sparing Whole Brain Radiation TherapyExperimental Treatment1 Intervention
Genu-sparing whole brain radiation therapy (GS-WBRT) 30 Gy in 3 Gy per fraction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
whole brain radiation therapy
2016
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,206 Total Patients Enrolled
Kristin Redmond, MD, MPHPrincipal InvestigatorThe SKCCC at Johns Hopkins
1 Previous Clinical Trials
40 Total Patients Enrolled
Kristin JansonPrincipal InvestigatorThe SKCCC at Johns Hopkins

Media Library

Genu-Sparing Whole Brain Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03223922 — N/A
Brain Tumor Research Study Groups: Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy
Brain Tumor Clinical Trial 2023: Genu-Sparing Whole Brain Radiation Therapy Highlights & Side Effects. Trial Name: NCT03223922 — N/A
Genu-Sparing Whole Brain Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03223922 — N/A
~3 spots leftby Dec 2025
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