LITT Followed by Hypofractionated RT for Recurrent Gliomas

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.

Conditions
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Glioblastoma, Brain Tumor, Glioma, Neoplasms

Intervention / Treatment
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* Device: Procedure: LITT
* Radiation: Hypo-Fractionated Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration History and physical including neurological exam within 30 days prior to registration Karnofsky performance status ≥ 60% within 30 days prior to registration Age ≥ 22 years old 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 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: LITT with Hypofractionated radiation therapy<br>Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions. | Device: Procedure: LITT<br>* This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.<br>* Other names: Laser Interstitial thermal therapy;Radiation: Hypo-Fractionated Radiation Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | To complete protocol treatment without undue treatment-related acute toxicity in recurrent or progressive glioma subjects undergoing LITT followed by hypofractionated radiation therapy. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival at 6 months | To describe progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy | 2 Years | 
| Median progression-free survival | 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. | 2 Years | 
| Median overall survival | 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. | 2 years | 
| 1-year overall survival | 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. | 2 years | 
| Overall response rate | To describe overall response survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy. | 2 years | 
| Quality of Life before, during, and after treatment | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma