Clinical trial · Interventional
LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
NCT05663125CI-TRIAL-00062883unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 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.
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 Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser interstitial thermal therapy | Procedure | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LITT with Early Application of Temozolomide
- description
- Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT).
- interventionNames
- Procedure: Laser interstitial thermal therapy
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
- From Day 1 throughout the study until 3 months
- description
- To complete protocol treatment without undue treatment-related acute toxicity in recurrent glioblastoma patients undergoing LITT followed by early use of temozolomide.
Secondary outcomes (2)
- measure
- Time to Progression (TTP)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.