Recurrent High Grade Glioma
Conditions
Keywords
laser interstitial thermal therapy, Recurrent High Grade Glioma
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.
Interventions
DEVICELITT
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.
OTHERControl
The patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted,
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The progression will be assessed by third-party blinded investigators
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Lesion ablation rate | within 2 days Post LITT | LITT group only, measured on enhanced MRI within 2 days post LITT |
| Lesion remaining volume | within 2 days Post LITT | LITT group only, measured on enhanced MRI within 2 days post LITT |
| Overall survival | up to 2 years | — |
| Karnofsky Performance Status (KPS) shift | Day 30,Day 90, Day 180 | The difference between baseline KPS and follow-up KPS |
Other
| Measure | Time frame | Description |
|---|---|---|
| specific AE rate | through study completion, an average of 6 month | Specific AE and complication including intracerebral hemorrhage, severe edema, newly seizure, local incision wound and all SAEs |
| bleeding volume | post LITT immmediatly | LITT group only during surgery |
Countries
China
Contacts
Primary ContactYunke Li, MD
Outcome results
None listed