Status:
RECRUITING
LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Keep Punching Foundation
Conditions:
Glioma
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with newly diagnosed gliomas...
Detailed Description
Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally ...
Eligibility Criteria
Inclusion
- Patients with radiographic evidence of suggestive of a primary high-grade glioma
- Brain MRI with contrast demonstrates an enhancing mass within 60 days prior to registration. Patient must be deemed a candidate for LITT from MRI by Neurosurgery in order to be eligible.
- History and physical including neurological exam within 30 days prior to registration
- Karnofsky performance status ≥50% within 30 days prior to registration
- Age ≥ 18 years old
- Patients must have signed an approved informed consent
- Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.
- Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.
Exclusion
- Patients that are not surgical candidates for stereotactic biopsy or laser ablation
- Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- History or presence of serious uncontrolled ventricular or significant arrhythmias.
- Any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism
- Infratentorial tumor or evidence of leptomeningeal spread
- Inability to undergo a MRI
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
February 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04699773
Start Date
February 20 2021
End Date
December 1 2027
Last Update
March 21 2025
Active Locations (5)
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1
Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201
2
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
3
UCH Kaufman Cancer Center
Bel Air, Maryland, United States, 21014
4
Central Maryland Radiation Oncology
Columbia, Maryland, United States, 21044