RECRUITING

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

Conditions

Glioma Glioblastoma Brain Tumor Laser Interstitial Thermal Therapy Radiotherapy Proton Therapy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-02-20

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04699773

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients with radiographic evidence of suggestive of a primary high-grade glioma 2. 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. 3. History and physical including neurological exam within 30 days prior to registration 4. Karnofsky performance status ≥50% within 30 days prior to registration 5. Age ≥ 18 years old 6. Patients must have signed an approved informed consent 7. 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. 8. Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.	1. Patients that are not surgical candidates for stereotactic biopsy or laser ablation 2. 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 3. Infratentorial tumor or evidence of leptomeningeal spread 4. Inability to undergo a MRI 5. Pregnant or breast-feeding women

Inclusion Criteria

Exclusion Criteria

1. Patients with radiographic evidence of suggestive of a primary high-grade glioma
2. 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.
3. History and physical including neurological exam within 30 days prior to registration
4. Karnofsky performance status ≥50% within 30 days prior to registration
5. Age ≥ 18 years old
6. Patients must have signed an approved informed consent
7. 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.
8. Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.

1. Patients that are not surgical candidates for stereotactic biopsy or laser ablation
2. 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
3. Infratentorial tumor or evidence of leptomeningeal spread
4. Inability to undergo a MRI
5. Pregnant or breast-feeding women

Contacts and Locations

Study Contact

Mark Mishra, MD

CONTACT

410-328-6080

mmishra@umm.edu

Caitlin Eggleston, BS

CONTACT

410-328-7586

caitlineggleston@umm.edu

Study Locations (Sites)

Maryland Proton Treatment Center

Baltimore, Maryland, 21201

United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

UCH Kaufman Cancer Center

Bel Air, Maryland, 21014

United States

Central Maryland Radiation Oncology

Columbia, Maryland, 21044

United States

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-20

Study Completion Date2027-12

Study Record Updates

Study Start Date2021-02-20

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Laser Interstitial Thermal Therapy
Brain Tumor
Radiotherapy
Proton Therapy
Glioma

Additional Relevant MeSH Terms

Glioma
Glioblastoma
Brain Tumor