Clinical trial · Interventional
Recurrent High Grade Glioma Treated by LITT
Randomized Clinical Trial of Efficiency and Safety of Recurrent High Grade Glioma Treated by Laser Interstitial Thermal Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent High Grade Glioma | High-Grade Glioma, NOS | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| LITT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LITT
- description
- LITT+potential other treatment
- interventionNames
- Device: LITT
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Best medical management under guidelines
- interventionNames
- Other: Control
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- estimate 6 months
- description
- The progression was defined by RANO 2.0 criteria and assessed by the third-party clinical events committees which are blinded to the allocation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 years old or above; 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: 1. Patients may benefit from other treatments or may not benefit from this trial; 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.
References
Publications (0)
Data not yet available