Health TrialsbyHealthPanel

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

ConditionsGliomaGlioblastomaBrain Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients that are not surgical candidates for stereotactic biopsy or laser ablation

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

Trial design

Design model

Single group

Treatments tested in this trial

  • LITT

    Procedure/Surgery

    This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.

  • 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.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: LITT with Hypofractionated RTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adverse Events

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

Time frame
2 years

Secondary outcomes

1

Progression-free survival at 6 months

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

Time frame
6 months
2

Median progression-free survival

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.

Time frame
2 years
3

Median overall survival

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.

Time frame
2 years
4

1-year overall survival

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Keep Punching Foundation

Collaborator

Source ClinicalTrials.gov
Apply now