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Recruiting

NCT Number: NCT04699773

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryland Proton Treatment Center, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LITT

Procedure

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

Hypofractionated Radiation Therapy

Radiation

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 outcomes

  1. Adverse Events

    Time frame: 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 outcomes

  1. Progression-free survival at 6 months

    Time frame: 6 months

    To describe progression-free survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy

  2. Median progression-free survival

    Time frame: 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.

  3. Median overall survival

    Time frame: 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.

  4. 1-year overall survival

    Time frame: 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.

  5. Overall response rate

    Time frame: 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.

  6. Quality of Life assessed by M.D. Anderson Symptom Inventory

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Eggleston, BS

CONTACT

[email protected]

410-328-7586

Mark Mishra, MD

CONTACT

[email protected]

410-328-6080

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Keep Punching Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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