This clinical trial determines the safety and effectiveness of the combination of laser interstitial thermal therapy and hypofractionated radiation therapy in treating patients with newly diagnosed high-grade gliomas. Laser-interstitial thermal therapy is a minimally-invasive treatment procedure that delivers thermal (heat) therapy, especially for brain tumors that can be hard to reach with conventional surgery. This method can be particularly useful for patients with a brain tumor that cannot be removed by surgery, or for patients who are not surgical candidates. Hypofractionated radiation therapy delivers either conventional (photon) or proton therapy at maximum dose to the tumor in a shorter amount of time with minimum toxicity to the normal tissue surrounding the tumor. Giving laser interstitial thermal therapy and hypofractionated radiation therapy may be effective at delaying or preventing the worsening of the tumor.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04699773.
Locations matching your search criteria
United States
Maryland
Baltimore
Maryland Proton Treatment CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
University of Maryland/Greenebaum Cancer CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
Bel Air
UM Upper Chesapeake Medical CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
Columbia
Central Maryland Radiation Oncology in Howard CountyStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
Glen Burnie
UM Baltimore Washington Medical Center/Tate Cancer CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
PRIMARY OBJECTIVE:
I. The ability to complete protocol treatment (i.e., laser interstitial thermal therapy [LITT] and radiation therapy) without undue treatment-related acute toxicity.
SECONDARY OBJECTIVES:
I. Progression-free survival at 6 months.
II. Median progression-free survival.
III. Median overall survival.
IV. 1-year overall survival.
V. Overall response rate.
VI. Quality of Life assessment.
OUTLINE:
Patients undergo LITT, then within 10-30 days, patients undergo hypofractionated radiation therapy once daily (QD) on consecutive treatment days over about 10 days.
After completion of study treatment, patients are followed up at 1 month, and then every 2 months for 2 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Maryland/Greenebaum Cancer Center
Principal InvestigatorMark V. Mishra