Recurrent High Grade Glioma Treated by LITT
- Conditions
- Recurrent High Grade Glioma
- Interventions
- Device: LITTOther: Control
- Registration Number
- NCT06161610
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 135
-
Aged 18 years old or above;
-
Patients with previous pathological diagnosis of 2021 World Health Organization Classification of Central Nervous System Tumors (WHO CNS5) grade 3 or 4 glioma and received standard treatment;
-
Meet any of the following:
- Meets the disease progression criteria in the Response Evaluation of Neuro-Oncology (RANO 2.0) criteria;
- At least one image other than T1 contrast indicates progression;
- Pathology shows progression or recurrence;
- Other progress determined by the Clinical Events Committee (CEC);
-
All tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the T1 contrast is β€30 mm;
-
Karnofsky score (KPS) β₯ 60 and the patient can tolerate the intervention;
-
The subjects or their agent can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form.
- Patients may benefit from other treatments or may not benefit from this trial;
- No more than three months since the patient underwent craniotomy;
- MRI contrast cannot be performed;
- Severe coagulation disorder;
- Women who are pregnant, lactating, or planning to become pregnant within 6 months;
- Participated in any other clinical trials of drugs or medical devices within 3 months;
- Combined diseases that may interfere with treatment or prognosis assessment;
- Refuse or unlikely to complete follow-up assessment;
- Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LITT LITT LITT+potential other treatment Control Control Best medical management under guidelines
- Primary Outcome Measures
Name Time Method Progression-free survival estimate 6 months The progression was defined by RANO 2.0 criteria and assessed by the third-party clinical events committees which are blinded to the allocation.
- Secondary Outcome Measures
Name Time Method Overall survival up to 2 years Lesion ablation rate within 2 days Post LITT LITT group only, measured on enhanced MRI within 2 days post LITT
Karnofsky Performance Status (KPS) shift Day 30,Day 90, Day 180 The difference between baseline KPS and follow-up KPS
Lesion remaining volume within 2 days Post LITT LITT group only, measured on enhanced MRI within 2 days post LITT
Trial Locations
- Locations (9)
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Tongji Hospital
π¨π³Wuhan, Hubei, China
The Peoples Hospital of Liaoning
π¨π³Shenyang, Liaoning, China
Beijing Tiantan Hospital
π¨π³Beijing, Beijing, China
Beijing Tsinghua Changgung Hospital
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Sun Yat-sen University
π¨π³Guangzhou, Guangdong, China
The First Hospital of Jilin University
π¨π³Changchun, Jilin, China
Qilu Hospital
π¨π³Jinan, Shandong, China
Huashan Hospital
π¨π³Shanghai, Shanghai, China