This clinical trial aims to investigate the efficiency and safety of laser interstitial thermal therapy (LITT) in recurrent high-grade glioma (rHGG) patients. The main questions it aims to answer are: * The LITT would increase the progression-free survival and overall survival of rHGG patients compared to other treatments. * The LITT is safe and applicable to rHGG patients Participants will be randomized to the intervention group (LITT) or control group at a ratio of 2:1. The intervention group patients will receive LITT. The control group will be treated with any other treatment. The primary outcome of this trial is progression-free survival. The estimated sample size is 135, 90 in the LITT group and 45 in the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
135
The patients in the intervention group will receive LITT, other treatments, including systematic therapy and radiology therapy, would be not restricted except the craniotomy of resection before tumor progression or emergency. The patient is supposed to receive LITT post-randomization within 7 days.
The patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted,
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGTongji Hospital
Wuhan, Hubei, China
RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGThe Peoples Hospital of Liaoning
Shenyang, Liaoning, China
RECRUITINGQilu Hospital
Jinan, Shandong, China
RECRUITINGHuashan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-free survival
The progression was defined by RANO 2.0 criteria and assessed by the third-party clinical events committees which are blinded to the allocation.
Time frame: estimate 6 months
Lesion ablation rate
LITT group only, measured on enhanced MRI within 2 days post LITT
Time frame: within 2 days Post LITT
Lesion remaining volume
LITT group only, measured on enhanced MRI within 2 days post LITT
Time frame: within 2 days Post LITT
Overall survival
Time frame: up to 2 years
Karnofsky Performance Status (KPS) shift
The difference between baseline KPS and follow-up KPS
Time frame: Day 30,Day 90, Day 180
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