Recurrent Glioblastoma
Conditions
Keywords
GBM, Glioblastoma, LITT, Laser Interstitial Thermal Therapy
Brief summary
This study aims to investigate the safety and efficacy of Laser Interstitial Thermal Therapy (LITT) combined with postoperative early use of temozolomide in treating recurrent glioblastomas.
Detailed description
This is an open-label, non-randomized Phase II study, planning to recruit about ten patients. The primary objective of this study is to investigate the safety of MRI-guided LITT in combination with the early application of temozolomide. The secondary outcome is to explore the efficacy of MRI-guided LITT combined with the early use of temozolomide in treating recurrent glioblastomas.
Interventions
PROCEDURELaser interstitial thermal therapy
Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.
DRUGTemozolomide
Temozolomide will be administered continuously from the 1st to the 21st day after LITT surgery. The oral dose of temozolomide is 75 mg/m2. And then, it will be given at a routine dose from the second month after surgery.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Imaging (PET-MRI) indicates tumor progression or recurrence 2. Patient ≥18 years old 3. The tumor was the first-time recurrence 4. The pathology of the tumor is glioblastoma (IDH wild-type, WHO grade 4) 5. MRI indicated a single tumor or multiple tumors with visual enhancement =\<3cm 6. Maximum tumor diameter: single tumor =\<3cm; Multiple tumors, targeted lesion =\<3cm 7. Single tumor or one of the multiple tumor lesions involved deep functional areas such as the insula lobe or thalamus 8. KPS score \>=60 within 30 days before treatment 9. No serious liver or kidney dysfunction 10. Patients must be able to understand how to sign the informed consent document
Exclusion criteria
1. The tumor crossed the midline or involved bilateral cerebral hemispheres 2. Inability to perform MRI examination or intolerance to MRI contrast agent 3. There is an active infection of the patient 4. The patient had abnormal coagulation function 5. Imaging before treatment indicated signs of cerebral hernia or midline displacement \> 1.0cm 6. The patient received radiotherapy, chemotherapy (including immunotherapy), or other therapeutic measures after tumor recurrence 7. Patients who have participated in clinical trials of any other drug or medical device within three months of the screening. 8. KPS score =\<50 points
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | From Day 1 throughout the study until 3 months | To complete protocol treatment without undue treatment-related acute toxicity in recurrent glioblastoma patients undergoing LITT followed by early use of temozolomide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression (TTP) | 12 months | TTP, defined as time from LITT to recorded tumor progression |
| Overall survival (OS) | 18 months | OS, defined as time from diagnosis to death |
Countries
China
Outcome results
None listed