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

NCT ID: NCT04699773

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-20
• Study Completion Date: 2027-12-31

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.

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.

Conditions

Glioma; Glioblastoma; Brain Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LITT with Hypofractionated RT

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

Group Type: EXPERIMENTAL

LITT

Intervention Type: PROCEDURE

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

Hypofractionated Radiation Therapy

Intervention Type: 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.

Interventions

LITT

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

Intervention Type: PROCEDURE

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.

Intervention Type: RADIATION

Other Intervention Names

Laser Interstitial thermal therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keep Punching Foundation

UNKNOWN

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Department of Radiation Oncology

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maryland Proton Treatment Center

Baltimore, Maryland, United States

Site Status: RECRUITING

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status: RECRUITING

UCH Kaufman Cancer Center

Bel Air, Maryland, United States

Site Status: RECRUITING

Central Maryland Radiation Oncology

Columbia, Maryland, United States

Site Status: RECRUITING

Baltimore Washington Medical Center

Glen Burnie, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark Mishra, MD

Role: CONTACT

mmishra@umm.edu

410-328-6080

Caitlin Eggleston, BS

Role: CONTACT

caitlineggleston@umm.edu

410-328-7586

Facility Contacts

Mark Mishra, MD

Role: primary

mmishra@umm.edu

4103286080

Caitlin Eggleston, BS

Role: backup

caitlineggleston@umm.edu

410-328-7586

Mark Mishra, MD

Role: primary

mmishra@umm.edu

410-328-6080

Caitlin Eggleston, BS

Role: backup

caitlineggleston@umm.edu

410-328-6080

Mark Mishra, MD

Role: primary

410-328-6080

Linda Romar

Role: backup

lromar@umm.edu

Mark Mishra, MD

Role: primary

410-328-6080

Caitlin Eggleston

Role: backup

caitlineggleston@umm.edu

Mark Mishra, MD

Role: primary

mmishra@umm.edu

410-328-6080

Pilar Strycula

Role: backup

P.Strycula@umm.edu

Other Identifiers

HP-00094285

Identifier Type: -

Identifier Source: org_study_id