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GCCC 19140: LITT Followed by Hypofractionated RT for Recurrent Gliomas

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Recruiting
CT.gov ID
NCT04181684
Collaborator
Keep Punching Foundation (Other)
32
Enrollment
4
Locations
1
Arm
36.8
Anticipated Duration (Months)
8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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 recurrent gliomas.

Condition or Disease Intervention/Treatment Phase
  • Device: Procedure: LITT
  • Radiation: Hypo-Fractionated Radiation Therapy
 N/A

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 recurrent tumor prior to initiating radiation therapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.
Actual Study Start Date :
Jan 8, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: LITT with Hypofractionated radiation therapy

Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.

Device: Procedure: LITT
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

    • Radiation: Hypo-Fractionated Radiation Therapy
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [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 Outcome Measures

    1. Progression-free survival at 6 months [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. 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

    1. Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration

    2. History and physical including neurological exam within 30 days prior to registration

    3. Karnofsky performance status ≥ 60% within 30 days prior to registration

    4. Age ≥ 22 years old

    5. 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

    1. Patients must have signed an approved informed consent

    2. 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.

    3. 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

    1. Infratentorial tumor or evidence of leptomeningeal spread

    2. Inability to undergo a MRI

    3. Pregnant or breast-feeding women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Maryland Greenebaum Cancer Center Baltimore Maryland United States 21201
    2 UCH Kaufman Cancer Center Bel Air Maryland United States 21014
    3 Central Maryland Radiation Oncology Columbia Maryland United States 21044
    4 Baltimore Washington Medical Center Glen Burnie Maryland United States 21061

    Sponsors and Collaborators

    • University of Maryland, Baltimore
    • Keep Punching Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Department of Radiation Oncology, Principal Investigator, University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT04181684
    Other Study ID Numbers:
    • HP-00088569
    First Posted:
    Nov 29, 2019
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.:
    Yes
    Keywords provided by Department of Radiation Oncology, Principal Investigator, University of Maryland, Baltimore
    Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma
    Additional relevant MeSH terms:
    Glioblastoma
    Glioma
    Brain Neoplasms

    Study Results

    No Results Posted as of Jul 22, 2021