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

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: Glioblastoma; Glioma; Brain Tumor

Treatments: Radiation: Hypofractionated Radiation Therapy; Procedure: LITT

Study type: Interventional

Funder types: Other

Identifiers

NCT04699773

HP-00094285

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

LITT with Hypofractionated RT

Experimental group

Description:

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

Treatment:

Procedure: LITT

Radiation: Hypofractionated Radiation Therapy