Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
135 participants
INTERVENTIONAL
2023-09-19
2027-09-19
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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LITT
LITT+potential other treatment
LITT
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.
Control
Best medical management under guidelines
Control
The patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted,
Interventions
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LITT
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.
Control
The patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted,
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. Meet any of the following:
1. Meets the disease progression criteria in the Response Evaluation of Neuro-Oncology (RANO 2.0) criteria;
2. At least one image other than T1 contrast indicates progression;
3. Pathology shows progression or recurrence;
4. Other progress determined by the Clinical Events Committee (CEC);
4. All tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the T1 contrast is ≤30 mm;
5. Karnofsky score (KPS) ≥ 60 and the patient can tolerate the intervention;
6. 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.
Exclusion Criteria
2. No more than three months since the patient underwent craniotomy;
3. MRI contrast cannot be performed;
4. Severe coagulation disorder;
5. Women who are pregnant, lactating, or planning to become pregnant within 6 months;
6. Participated in any other clinical trials of drugs or medical devices within 3 months;
7. Combined diseases that may interfere with treatment or prognosis assessment;
8. Refuse or unlikely to complete follow-up assessment;
9. Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.
18 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Dabiao Zhou, MD
MD
Principal Investigators
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Tao Jiang, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital
Wuhan, Hubei, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Peoples Hospital of Liaoning
Shenyang, Liaoning, China
Qilu Hospital
Jinan, Shandong, China
Huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yi Guo, MD
Role: primary
Nu Zhang, MD
Role: primary
Dongming Yan, MD
Role: primary
Kai Shu, MD
Role: primary
Yunqian Li, MD
Role: primary
Peizhuo Zang, MD
Role: primary
Shilei Ni, MD
Role: primary
Jinsong Wu, MD
Role: primary
Other Identifiers
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REGALITT
Identifier Type: -
Identifier Source: org_study_id