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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Adverse Events [Time frame: 2 years]

Secondary outcome measures (6)

• Progression-free survival at 6 months [Time frame: 6 months]
• Median progression-free survival [Time frame: 2 years]
• Median overall survival [Time frame: 2 years]
• 1-year overall survival [Time frame: 1 year]
• Overall response rate [Time frame: 2 years]
• Quality of Life assessed by M.D. Anderson Symptom Inventory [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 5 centers

• Maryland Proton Treatment Center — Baltimore
• University of Maryland Greenebaum Cancer Center — Baltimore
• UCH Kaufman Cancer Center — Bel Air
• Central Maryland Radiation Oncology — Columbia
• Baltimore Washington Medical Center — Glen Burnie

Identifiers

NCT: NCT04699773 · HP-00094285

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗