LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Study Overview
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Brief Summary
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This study aims to investigate the safety and efficacy of Laser Interstitial Thermal Therapy (LITT) combined with postoperative early use of temozolomide in treating recurrent glioblastomas.

Detailed Description
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This is an open-label, non-randomized Phase II study, planning to recruit about ten patients. The primary objective of this study is to investigate the safety of MRI-guided LITT in combination with the early application of temozolomide. The secondary outcome is to explore the efficacy of MRI-guided LITT combined with the early use of temozolomide in treating recurrent glioblastomas.

Official Title
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Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Conditions
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Recurrent Glioblastoma

Intervention / Treatment
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* Procedure: Laser interstitial thermal therapy
* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Imaging (PET-MRI) indicates tumor progression or recurrence Patient ≥18 years old The tumor was the first-time recurrence The pathology of the tumor is glioblastoma (IDH wild-type, WHO grade 4) MRI indicated a single tumor or multiple tumors with visual enhancement =<3cm Maximum tumor diameter: single tumor =<3cm; Multiple tumors, targeted lesion =<3cm Single tumor or one of the multiple tumor lesions involved deep functional areas such as the insula lobe or thalamus KPS score >=60 within 30 days before treatment No serious liver or kidney dysfunction Patients must be able to understand how to sign the informed consent document Exclusion Criteria: The tumor crossed the midline or involved bilateral cerebral hemispheres Inability to perform MRI examination or intolerance to MRI contrast agent There is an active infection of the patient The patient had abnormal coagulation function Imaging before treatment indicated signs of cerebral hernia or midline displacement > 1.0cm The patient received radiotherapy, chemotherapy (including immunotherapy), or other therapeutic measures after tumor recurrence Patients who have participated in clinical trials of any other drug or medical device within three months of the screening. KPS score =<50 points

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: LITT with Early Application of Temozolomide<br>Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT). | Procedure: Laser interstitial thermal therapy<br>* Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.<br>* Other names: LITT;Drug: Temozolomide<br>* Temozolomide will be administered continuously from the 1st to the 21st day after LITT surgery. The oral dose of temozolomide is 75 mg/m2. And then, it will be given at a routine dose from the second month after surgery.<br>* Other names: TMZ;|

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 glioblastoma patients undergoing LITT followed by early use of temozolomide. | From Day 1 throughout the study until 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression (TTP) | TTP, defined as time from LITT to recorded tumor progression | 12 months | 
| Overall survival (OS) | OS, defined as time from diagnosis to death | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GBM, Glioblastoma, LITT, Laser Interstitial Thermal Therapy