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

Primary Purpose

Glioma, Glioblastoma, Brain Tumor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LITT
Hypofractionated Radiation Therapy
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring Laser Interstitial Thermal Therapy, Brain Tumor, Radiotherapy, Proton Therapy, Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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.

Exclusion Criteria:

  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

Sites / Locations

  • Maryland Proton Treatment CenterRecruiting
  • University of Maryland Greenebaum Cancer Center
  • UCH Kaufman Cancer CenterRecruiting
  • Central Maryland Radiation OncologyRecruiting
  • Baltimore Washington Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LITT with Hypofractionated RT

Arm Description

Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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.
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.
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.

Full Information

First Posted
January 4, 2021
Last Updated
March 1, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
Keep Punching Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04699773
Brief Title
LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)
Official Title
Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Keep Punching Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Glioblastoma, Brain Tumor
Keywords
Laser Interstitial Thermal Therapy, Brain Tumor, Radiotherapy, Proton Therapy, Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LITT with Hypofractionated RT
Arm Type
Experimental
Arm Description
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions.
Intervention Type
Procedure
Intervention Name(s)
LITT
Other Intervention Name(s)
Laser Interstitial thermal therapy
Intervention Description
This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiation Therapy
Intervention Description
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 Outcome Measure Information:
Title
Adverse Events
Description
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 Outcome Measure Information:
Title
Progression-free survival at 6 months
Description
To describe progression-free survival rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy
Time Frame
6 months
Title
Median progression-free survival
Description
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
Title
Median overall survival
Description
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
Title
1-year overall survival
Description
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
Title
Overall response rate
Description
To describe overall response rate in subjects with newly diagnosed high-grade gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Time Frame
2 years
Title
Quality of Life assessed by M.D. Anderson Symptom Inventory
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Mishra, MD
Phone
410-328-6080
Email
mmishra@umm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Eggleston, BS
Phone
410-328-7586
Email
caitlineggleston@umm.edu
Facility Information:
Facility Name
Maryland Proton Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mishra, MD
Phone
410-328-6080
Email
mmishra@umm.edu
First Name & Middle Initial & Last Name & Degree
Caitlin Eggleston, BS
Phone
410-328-7586
Email
caitlineggleston@umm.edu
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mishra, MD
Phone
410-328-6080
Email
mmishra@umm.edu
First Name & Middle Initial & Last Name & Degree
Caitlin Eggleston, BS
Phone
410-328-6080
Email
caitlineggleston@umm.edu
Facility Name
UCH Kaufman Cancer Center
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mishra, MD
Phone
410-328-6080
First Name & Middle Initial & Last Name & Degree
Linda Romar
Email
lromar@umm.edu
Facility Name
Central Maryland Radiation Oncology
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mishra, MD
Phone
410-328-6080
First Name & Middle Initial & Last Name & Degree
Caitlin Eggleston
Email
caitlineggleston@umm.edu
Facility Name
Baltimore Washington Medical Center
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mishra, MD
Phone
410-328-6080
Email
mmishra@umm.edu
First Name & Middle Initial & Last Name & Degree
Pilar Strycula
Email
P.Strycula@umm.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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