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

NCT04699773 | Recruiting DMC FDA Device

• 1 other identifier: HP-00094285
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Glioma; Glioblastoma; Brain Tumor

Keywords

Laser Interstitial Thermal Therapy; Brain Tumor; Radiotherapy; Proton Therapy; Glioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Progression-free survival at 6 months

  6 months

• Median progression-free survival

  2 years

• Median overall survival

  2 years

• 1-year overall survival

  1 year

• Overall response rate

  2 years

Study Arms (1)

LITT with Hypofractionated RT

EXPERIMENTAL

Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions.

Procedure: LITT; Radiation: Hypofractionated Radiation Therapy

Interventions

LITT PROCEDURE

This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.

Also known as: Laser Interstitial thermal therapy

LITT with Hypofractionated RT

Hypofractionated Radiation Therapy RADIATION

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.

LITT with Hypofractionated RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with radiographic evidence of suggestive of a primary high-grade glioma
• 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.
• History and physical including neurological exam within 30 days prior to registration
• Karnofsky performance status ≥50% within 30 days prior to registration
• Age ≥ 18 years old
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Keep Punching Foundation: collaborator

Study Sites (5)

Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States

RECRUITING

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

UCH Kaufman Cancer Center

Bel Air, Maryland, 21014, United States

RECRUITING

Central Maryland Radiation Oncology

Columbia, Maryland, 21044, United States

RECRUITING

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

RECRUITING

MeSH Terms

Conditions

Glioma; Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Mark Mishra, MD

CONTACT

410-328-6080; mmishra@umm.edu

Caitlin Eggleston, BS

CONTACT

410-328-7586; caitlineggleston@umm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 7, 2021
• Study Start: February 20, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)