Clinical trial NCT04699773: LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)
Official title: Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade Gliomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma
Glioblastoma
Brain Tumor
Keywords: Laser Interstitial Thermal Therapy
Brain Tumor
Radiotherapy
Proton Therapy
Glioma
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Keep Punching Foundation
First posted: 2021-01-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adverse Events
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival at 6 months
timeFrame: 6 months
measure: Median progression-free survival
timeFrame: 2 years
measure: Median overall survival
timeFrame: 2 years
measure: 1-year overall survival
timeFrame: 1 year
measure: Overall response rate
timeFrame: 2 years
measure: Quality of Life assessed by M.D. Anderson Symptom Inventory
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Maryland Proton Treatment Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Cancer Center
state: Maryland
city: Bel Air
country: United States
facility: UCH Kaufman Cancer Center
state: Maryland
city: Columbia
country: United States
facility: Central Maryland Radiation Oncology
state: Maryland
city: Glen Burnie
country: United States
facility: Baltimore Washington Medical Center
state: Maryland
Study officials:
References: