GliomaNCT04699773
LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)
A study testing LITT and Hypofractionated Radiation Therapy in people with Glioma and Glioblastoma, run by University of Maryland, Baltimore at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma, Brain Tumor
- What is being tested?
- LITT and Hypofractionated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Feb 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Mark Mishra, MD, 4103286080, mmishra@umm.edu
Caitlin Eggleston, BS, 410-328-7586, caitlineggleston@umm.edu
- Recruiting
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Mark Mishra, MD, 410-328-6080, mmishra@umm.edu
Caitlin Eggleston, BS, 410-328-6080, caitlineggleston@umm.edu
- Recruiting
UCH Kaufman Cancer Center
Bel Air, Maryland, 21014
Mark Mishra, MD, 410-328-6080
Linda Romar, lromar@umm.edu
- Recruiting
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
Mark Mishra, MD, 410-328-6080
Caitlin Eggleston, caitlineggleston@umm.edu
- Recruiting
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Mark Mishra, MD, 410-328-6080, mmishra@umm.edu
Pilar Strycula, P.Strycula@umm.edu
About this study
Official title: Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade 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 newly diagnosed gliomas.
Read the 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.
- Conditions
- Glioma, Glioblastoma, Brain Tumor
- Being tested
- LITT, Hypofractionated Radiation Therapy
- Keywords
- Laser Interstitial Thermal Therapy, Brain Tumor, Radiotherapy, Proton Therapy, Glioma
- Medical subject headings
- Glioma, Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LITTProcedure or surgery
Also called Laser Interstitial thermal therapy
This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
Hypofractionated Radiation TherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| LITT with Hypofractionated RT | Experimental | Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions. Receives: Procedure: LITT; Radiation: Hypofractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (6)
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
Measured: 6 months
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 1 year
Overall response rate
To describe overall response rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Measured: 2 years
Quality of Life assessed by M.D. Anderson Symptom Inventory
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start20 Feb 2021
- Primary completionFeb 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Keep Punching Foundation
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699773
- Sponsor's protocol ID
- HP-00094285
- Status last verified
- May 2026
- First submitted
- 4 Jan 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade Gliomas
- ClinicalTrials.gov ID
- NCT04699773
- Acronym / sponsor ID
- HP-00094285
- Conditions
- Glioma, Glioblastoma, Brain Tumor
- Keywords
- Laser Interstitial Thermal Therapy, Brain Tumor, Radiotherapy, Proton Therapy, Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Keep Punching Foundation
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LITT with Hypofractionated RT | Experimental | Procedure: LITT, Radiation: Hypofractionated Radiation TherapyLaser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
- Infratentorial tumor or evidence of leptomeningeal spread
- Inability to undergo a MRI
- Pregnant or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LITTAlso: Laser Interstitial thermal therapyThis procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation. | Procedure or surgery | LITT with Hypofractionated RT |
| Hypofractionated Radiation TherapyTreatments 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. | Radiation | LITT with Hypofractionated RT |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LITT and Hypofractionated Radiation Therapy in people with Glioma and Glioblastoma, run by University of Maryland, Baltimore at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Mishra, MD (410-328-6080, mmishra@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.