LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)

Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade Gliomas

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma; Glioblastoma; Brain Tumor
• Intervention / Treatment: Procedure: LITT; Radiation: Hypofractionated Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Mishra, MD; Phone Number: 410-328-6080; Email: mmishra@umm.edu
• Study Contact Backup: Name: Caitlin Eggleston, BS; Phone Number: 410-328-7586; Email: caitlineggleston@umm.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Greenebaum Cancer Center
      • Contact: Mark Mishra, MD; Phone Number: 410-328-6080; Email: mmishra@umm.edu
      • Contact: Caitlin Eggleston, BS; Phone Number: 410-328-6080; Email: caitlineggleston@umm.edu
      • Sub-Investigator: Graeme Woodworth, MD
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Maryland Proton Treatment Center
      • Contact: Mark Mishra, MD; Phone Number: 4103286080; Email: mmishra@umm.edu
      • Contact: Caitlin Eggleston, BS; Phone Number: 410-328-7586; Email: caitlineggleston@umm.edu
    • Bel Air, Maryland, United States, 21014
      • Recruiting
      • UCH Kaufman Cancer Center
      • Contact: Mark Mishra, MD; Phone Number: 410-328-6080
      • Contact: Linda Romar; Email: lromar@umm.edu
    • Columbia, Maryland, United States, 21044
      • Recruiting
      • Central Maryland Radiation Oncology
      • Contact: Mark Mishra, MD; Phone Number: 410-328-6080
      • Contact: Caitlin Eggleston; Email: caitlineggleston@umm.edu
    • Glen Burnie, Maryland, United States, 21061
      • Recruiting
      • Baltimore Washington Medical Center
      • Contact: Mark Mishra, MD; Phone Number: 410-328-6080; Email: mmishra@umm.edu
      • Contact: Pilar Strycula; Email: P.Strycula@umm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with radiographic evidence of suggestive of a primary high-grade glioma
2. 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.
3. History and physical including neurological exam within 30 days prior to registration
4. Karnofsky performance status ≥50% within 30 days prior to registration
5. Age ≥ 18 years old
6. Patients must have signed an approved informed consent
7. 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.
8. Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.

Exclusion Criteria:

1. Patients that are not surgical candidates for stereotactic biopsy or laser ablation

2. 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
3. Infratentorial tumor or evidence of leptomeningeal spread
4. Inability to undergo a MRI
5. Pregnant or breast-feeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: LITT with Hypofractionated RT; Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions.

Procedure: LITT; This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.; Other Names: Laser Interstitial thermal therapy; Radiation: Hypofractionated 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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.	2 years

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Keep Punching Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Glioma; Brain Tumor; Radiotherapy; Proton Therapy; Laser Interstitial Thermal Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Central Nervous System Neoplasms; Glioblastoma; Glioma; Brain Neoplasms
• Other Study ID Numbers: HP-00094285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No