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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LITT with Early Application of Temozolomide | Experimental | Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser interstitial thermal therapy | Procedure | Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | To complete protocol treatment without undue treatment-related acute toxicity in recurrent glioblastoma patients undergoing LITT followed by early use of temozolomide. | From Day 1 throughout the study until 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | TTP, defined as time from LITT to recorded tumor progression | 12 months |
| Overall survival (OS) | OS, defined as time from diagnosis to death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dabiao Zhou, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
| Temozolomide | Drug | 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. |
|
|
| 18 months |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |