LITT Followed by Hypofractionated RT for Recurrent Gliomas

Recruiting now · Not applicable

Conditions studied: Glioblastoma, Brain Tumor, Glioma, Neoplasms

In brief

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 recurrent gliomas.

Key facts

Study ID

NCT04181684

Run by

University of Maryland, Baltimore

People needed

32

Starts

2020-01-08

Expected to finish

2026-12-01

Last updated by the study team

2026-01-23

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor
• Patient must have received prior radiation therapy for initial treatment of glioma
• Patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation
• Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
• History and physical including neurological exam within 30 days prior to registration
• Karnofsky performance status ≥ 60% within 30 days prior to registration
• Age ≥ 22 years old
• Minimum interval since completion of prior radiation treatment is 8 weeks
• Patients will only receive re-irradiation if pathology from LITT is consistent with recurrent tumor
• 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.

You may not qualify if…

• 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

Where it is running

• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States (enrolling)
• UCH Kaufman Cancer Center — Bel Air, Maryland, United States (enrolling)
• Central Maryland Radiation Oncology — Columbia, Maryland, United States (enrolling)
• Baltimore Washington Medical Center — Glen Burnie, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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