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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699773
• Other study ID #: HP-00094285
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2021
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: University of Maryland, Baltimore
• Contact: Mark Mishra, MD
• Phone: 410-328-6080
• Email: mmishra[@]umm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2027
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Glioblastoma
• Glioma

Intervention

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

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.

Locations

Country	Name	City	State
United States	Maryland Proton Treatment Center	Baltimore	Maryland
United States	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland
United States	UCH Kaufman Cancer Center	Bel Air	Maryland
United States	Central Maryland Radiation Oncology	Columbia	Maryland
United States	Baltimore Washington Medical Center	Glen Burnie	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Keep Punching Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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