LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
NCT ID: NCT05663125
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2022-12-01
2024-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LITT with Early Application of Temozolomide
Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT).
Laser interstitial thermal therapy
Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.
Temozolomide
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.
Interventions
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Laser interstitial thermal therapy
Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.
Temozolomide
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Dabiao Zhou, MD
Clinical Professor
Principal Investigators
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Dabiao Zhou, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital
Beijing, , China
Countries
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Other Identifiers
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KY2022-232-01
Identifier Type: -
Identifier Source: org_study_id