Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04181684

LITT Followed by Hypofractionated RT for Recurrent Gliomas

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 recurrent gliomas.

Recruiting

Interested in participating?

Request Info

Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States

Loading trial locations.

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 recurrent 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 history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor
  • Patient must have received prior radiation therapy for initial treatment of glioma
  • Patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation
  • Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
  • History and physical including neurological exam within 30 days prior to registration
  • Karnofsky performance status ≥ 60% within 30 days prior to registration
  • Age ≥ 22 years old
  • Minimum interval since completion of prior radiation treatment is 8 weeks
  • Patients will only receive re-irradiation if pathology from LITT is consistent with recurrent tumor
  • 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

Procedure: LITT

Device

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

Hypo-Fractionated 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

    To complete protocol treatment without undue treatment-related acute toxicity in recurrent or progressive glioma subjects undergoing LITT followed by hypofractionated radiation therapy.

Secondary outcomes

  1. Progression-free survival at 6 months

    Time frame: 2 Years

    To describe progression-free survival rate in subjects with recurrent or progressive 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 recurrent or progressive 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 recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.

  4. 1-year overall survival

    Time frame: 2 years

    To describe 1 year overall survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.

  5. Overall response rate

    Time frame: 2 years

    To describe overall response survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.

  6. Quality of Life before, during, and after treatment

    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.

Mark Mishra, MD

CONTACT

[email protected]

410-328-6080

Megan A Camara, RN

CONTACT

[email protected]

410-369-5355

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Keep Punching Foundation

Registry information

Official study title

Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.

Acronym: GCCC 19140

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2019
Registry last updated
Jan 23, 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.

Published trials that share one or more normalized conditions with this study.