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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.
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.
Beijing Tiantan Hospital
Beijing, China
Adverse Events
To complete protocol treatment without undue treatment-related acute toxicity in recurrent glioblastoma patients undergoing LITT followed by early use of temozolomide.
Time frame: From Day 1 throughout the study until 3 months
Time to Progression (TTP)
TTP, defined as time from LITT to recorded tumor progression
Time frame: 12 months
Overall survival (OS)
OS, defined as time from diagnosis to death
Time frame: 18 months
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