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Radiation Therapy

LITT + Radiation Therapy for Brain Tumor

N/A
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History and physical including neurological exam within 30 days prior to registration
Age ≥ 18 years old
Must not have
Infratentorial tumor or evidence of leptomeningeal spread
Patients that are not surgical candidates for stereotactic biopsy or laser ablation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with newly diagnosed gliomas.

Who is the study for?
This trial is for adults over 18 with newly diagnosed gliomas, a type of brain tumor. They must be able to undergo MRI scans and have a Karnofsky performance status of at least 50%, indicating they can care for themselves. Women who can become pregnant must test negative for pregnancy and use effective contraception during the study.
What is being tested?
The trial tests a treatment regimen combining Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy on patients with new gliomas. LITT uses lasers to destroy tumor cells, followed by targeted radiation therapy in fewer high-dose sessions.
What are the potential side effects?
Potential side effects may include discomfort or complications from laser surgery, skin irritation or damage from radiation, fatigue, headaches, swelling in the brain area treated, and possible changes in neurological function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had a full physical and neurological exam in the last 30 days.
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I am 18 years old or older.
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My scans suggest I have a high-grade brain tumor.
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I can do most of my daily activities by myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to the lower part of my brain or its lining.
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I cannot undergo surgery for a stereotactic biopsy or laser ablation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Secondary study objectives
1-year overall survival
Median overall survival
Median progression-free survival
+3 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: LITT with Hypofractionated RTExperimental Treatment2 Interventions
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~130

Find a Location

Who is running the clinical trial?

Keep Punching FoundationUNKNOWN
1 Previous Clinical Trials
32 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,460 Total Patients Enrolled

Media Library

Hypofractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04699773 — N/A
Brain Tumor Research Study Groups: LITT with Hypofractionated RT
Brain Tumor Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT04699773 — N/A
Hypofractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04699773 — N/A
~1 spots leftby Feb 2025
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