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Radiation
LITT + Radiation for Brain Tumor (GCCC 19140 Trial)
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
Age ≥ 22 years old
Patient must have received prior radiation therapy for initial treatment of glioma
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 way to treat patients with brain tumors that have come back. The treatment involves using a laser to heat up and destroy the tumor, and then using radiation to kill any remaining cancer cells.
Who is the study for?
This trial is for adults over 22 with recurrent WHO Grade II-IV gliomas, who've had prior radiation therapy. They must have a tumor ≤ 6 cm, not undergone re-irradiation, and be in good enough health to undergo surgery. Women of childbearing age need a negative pregnancy test and all participants must agree to use contraception.
What is being tested?
The study tests using Laser Interstitial Thermal Therapy (LITT) followed by Hypo-fractionated Radiation Therapy on patients with recurring brain tumors called gliomas. It aims to see how effective this combination is for treatment after initial therapies have failed.
What are the potential side effects?
Potential side effects may include typical risks associated with surgical procedures like LITT and radiation therapy such as infection, bleeding, neurological damage or deficits, fatigue from radiation, skin irritation at the treatment site, and other organ-specific reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
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I have had radiation therapy for my brain tumor before.
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I can care for myself but may need occasional help.
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My brain tumor has come back or gotten worse after treatment.
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It has been at least 8 weeks since my last radiation treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to the lower part of my brain or its lining.
Select...
I cannot undergo surgery for a stereotactic biopsy or laser ablation.
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I have heart problems that affect my daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreAwards & 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: Experimental: LITT with Hypofractionated radiation therapyExperimental Treatment2 Interventions
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,460 Total Patients Enrolled
3 Trials studying Glioblastoma
63 Patients Enrolled for Glioblastoma
Keep Punching FoundationUNKNOWN
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Glioblastoma
32 Patients Enrolled for Glioblastoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to the lower part of my brain or its lining.My brain MRI shows a tumor 6 cm or smaller.I am 22 years old or older.You cannot have a MRI scan.I have had radiation therapy for my brain tumor before.I have had cancer come back but haven't had repeat radiation therapy.I am a woman who can have children and I have a negative pregnancy test from the last 28 days.I will only get more radiation if tests after my laser therapy show cancer has returned.I cannot undergo surgery for a stereotactic biopsy or laser ablation.I have heart problems that affect my daily activities.I can care for myself but may need occasional help.My brain tumor has come back or gotten worse after treatment.It has been at least 8 weeks since my last radiation treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: LITT with Hypofractionated radiation therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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