Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade Gliomas
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 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.
Arms & interventions
- ProcedureLITT
This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
- RadiationHypofractionated Radiation Therapy
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.
Outcome measures
Primary
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
Secondary
Progression-free survival at 6 months
Time frame: 6 months
Median progression-free survival
Time frame: 2 years
Median overall survival
Time frame: 2 years
1-year overall survival
Time frame: 1 year
Overall response rate
Time frame: 2 years
Quality of Life assessed by M.D. Anderson Symptom Inventory
Time frame: 2 years
Eligibility criteria
Study locations (5)
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
UCH Kaufman Cancer Center
Bel Air, Maryland, 21014
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061