Clinical TrialID 8041
Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recurrent High-grade Gliomas
NCT05737212
Recurrent High-grade Glioma|Recurrent Glioblastoma|Recurrent Anaplastic Astrocytoma|Recurrent Anaplastic Oligodendroglioma
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8041
- Evidence Id
- 8041
- Core Evidence Id
- 8041
- Source Clinical Trial Id
- 8037
- Herb2 Clinical Trial Id
- HBCT008037
- Nct Id
- NCT05737212
- Title
- Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recurrent High-grade Gliomas
- Status
- Recruiting
- Phase
- Phase 1|Phase 2
- Study Result
- No
- Study Condition
- Recurrent High-grade Glioma|Recurrent Glioblastoma|Recurrent Anaplastic Astrocytoma|Recurrent Anaplastic Oligodendroglioma
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- RADIATION: 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 9Gy-Eq|RADIATION: 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 11Gy-Eq|RADIATION: 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 13Gy-Eq
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Sequential
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 39
- Outcome Measure
- Phase I: To explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose of BNCT, To explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose (radiation dose) of BNCT in patients with recurrent high-grade gliomas, During 90 days post-BNCT|Phase IIa: Proportion of 6-month PFS evaluated by central imaging according to the modified RANO criteria, Percentage of patients that are free from progressive disease for 6 months per modified RANO criteria, 6 months
- Sponsor Collaborator
- Dawonmedax Co., Ltd.
- Funded By
- INDUSTRY
- Location
- Gachon University Gil Medical Center, Incheon, Korea, Republic of
- Other Id
- DM-BNCT-P001
- Start Date
- 2022-12-05
- Primary Completion Date
- 2024-06
- Completion Date
- 2024-12
- First Posted
- 2023-02-21
- Results First Posted
- Last Update Posted
- 2024-02-20
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05737212
- Title Cn
- Title En
- Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recurrent High-grade Gliomas
- Bilingual Status
- semi_complete