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.
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 invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of the tumor prior to initiating radiation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.
Maryland Proton Treatment Center
Baltimore, Maryland, United States
RECRUITINGUniversity of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
RECRUITINGUCH Kaufman Cancer Center
Bel Air, Maryland, United States
Adverse Events
The ability to complete protocol treatment (i.e. LITT and radiation therapy) without undue treatment-related acute toxicity as defined below: * Safety: \< 40% rate of irreversible Grade 3 or higher neurologic treatment-related toxicity * Early stopping rules: Two or more Grade 2 or higher symptomatic CNS hemorrhages; Eight treatment-related Grade 3 or higher non-hematologic or Grade 4 or higher hematologic treatment related toxicities
Time frame: 2 years
Progression-free survival at 6 months
To describe progression-free survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy
Time frame: 6 months
Median progression-free survival
To describe median progression-free survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Time frame: 2 years
Median overall survival
To describe median progression-free survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Time frame: 2 years
1-year overall survival
To describe 1- year survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Time frame: 1 year
Overall response rate
To describe overall response rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
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Central Maryland Radiation Oncology
Columbia, Maryland, United States
RECRUITINGBaltimore Washington Medical Center
Glen Burnie, Maryland, United States
RECRUITINGTime frame: 2 years
Quality of Life assessed by M.D. Anderson Symptom Inventory
Patient reported quality of life impact from undergoing LITT followed by hypofractionated radiation therapy using the M.D. Anderson Symptom Inventory- Brain Tumor (MDASI-BT) questionnaire.
Time frame: 2 years