NCT06161610招募中不适用
Randomized Clinical Trial of Efficiency and Safety of Recurrent High Grade Glioma Treated by Laser Interstitial Thermal Therapy
Beijing Tiantan Hospital9 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2023年9月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 9
- 主要终点
- Progression-free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The progression will be assessed by third-party blinded investigators
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤30 mm;
- •Karnofsky score (KPS) ≥ 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.
排除标准
- •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.
结局指标
主要结局
Progression-free survival
时间窗: 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.
次要结局
- Overall survival(up to 2 years)
- Lesion ablation rate(within 2 days Post LITT)
- Karnofsky Performance Status (KPS) shift(Day 30,Day 90, Day 180)
- Lesion remaining volume(within 2 days Post LITT)
研究者
Dabiao Zhou, MD
MD
Beijing Tiantan Hospital
研究点 (9)
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