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

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Recruiting

CT.gov ID

NCT04699773

Collaborator

Keep Punching Foundation (Other)

Enrollment

Locations

Arm

57.3

Anticipated Duration (Months)

6.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma Glioblastoma Brain Tumor	Procedure: LITT Radiation: Hypofractionated Radiation Therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 20, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Adverse Events [2 years]
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

Secondary Outcome Measures

Progression-free survival at 6 months [6 months]
To describe progression-free survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy
Median progression-free survival [2 years]
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.
Median overall survival [2 years]
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.
1-year overall survival [1 year]
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.
Overall response rate [2 years]
To describe overall response rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Quality of Life assessed by M.D. Anderson Symptom Inventory [2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maryland Proton Treatment Center	Baltimore	Maryland	United States	21201
2	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland	United States	21201
3	UCH Kaufman Cancer Center	Bel Air	Maryland	United States	21014
4	Central Maryland Radiation Oncology	Columbia	Maryland	United States	21044
5	Baltimore Washington Medical Center	Glen Burnie	Maryland	United States	21061