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LITT Followed by Hypofractionated RT for Recurrent Gliomas (GCCC 19140)

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ClinicalTrials.gov Identifier: NCT04181684
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : July 22, 2021
Sponsor:
Collaborator:
Keep Punching Foundation
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE November 24, 2019
First Posted Date  ICMJE November 29, 2019
Last Update Posted Date July 22, 2021
Actual Study Start Date  ICMJE January 8, 2020
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
Adverse Events [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • Progression-free survival at 6 months [ Time Frame: 2 Years ]
    To describe progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy
  • Median progression-free survival [ Time Frame: 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.
  • Median overall survival [ Time Frame: 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.
  • 1-year overall survival [ Time Frame: 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.
  • Overall response rate [ Time Frame: 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.
  • Quality of Life before, during, and after treatment [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LITT Followed by Hypofractionated RT for Recurrent Gliomas
Official Title  ICMJE Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioblastoma
  • Brain Tumor
  • Glioma
  • Neoplasms
Intervention  ICMJE
  • Device: Procedure: LITT
    This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
    Other Name: 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.
Study Arms  ICMJE Experimental: Experimental: LITT with Hypofractionated radiation therapy
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.
Interventions:
  • Device: Procedure: LITT
  • Radiation: Hypo-Fractionated Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2019)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  2. Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
  3. History and physical including neurological exam within 30 days prior to registration
  4. Karnofsky performance status ≥ 60% within 30 days prior to registration
  5. Age ≥ 22 years old
  6. 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
  7. Patients must have signed an approved informed consent
  8. 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.
  9. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Mishra, MD 410-328-6080 mmishra@umm.edu
Contact: Jasmine A Newman, BS 410-369-5355 jasmine.newman@umm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04181684
Other Study ID Numbers  ICMJE HP-00088569
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Department of Radiation Oncology, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Keep Punching Foundation
Investigators  ICMJE Not Provided
PRS Account University of Maryland, Baltimore
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP