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| ID | Type | Description | Link |
|---|---|---|---|
| 2019YFE0120100 | Other Grant/Funding Number | MOST |
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The purpose of this study is to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.
This is a prospective, multicentric open-label trial to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.
The primary efficacy outcome was evaluated with progression-free survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodine-125+Chemotherapy | Experimental | Iodine-125; Temozolomide |
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| Surgical resection+Radiochemotherapy | Active Comparator | Surgical resection; Radiotherapy; Temozolomide: |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodine-125+Chemotherapy | Other | Iodine-125: Iodine-125 if necessary, 0.6-0.8mCi, PD:120-150Gy Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS is defined as the time from randomization to progression or death from any causes. Progression is defined as the RANO Criteria indicated. | 2.5 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death from any causes. | 2.5 years after randomization |
| Survival rates at 6 months and 1 year | The survival rates were measured at 6 months and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaokun Hu, PhD | Contact | +8618661801166 | huxiaokun770@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaokun Hu, MD | The Affiliated Hospital of Qingdao University | Principal Investigator |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| Surgical resection+Radiochemotherapy | Other | Surgical resection: Maximal surgical resection, including gross total resection, subtotal resection, and partial resection. Radiation: total 60 Gy, 2 Gy per daily fraction (Monday to Friday) for 6 weeks. Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days. |
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| at 6 months and 1 year after operation respectively |
| EORTC QLQ-C30 | The Quality of life is measured with EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire). The EORTC QLQ-C30 is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. | 2.5 year after randomization |
| ECOG Performance Status | ECOG PS (Eastern Cooperative Oncology Group, performance status) is to assess how a patient's disease is progressing, and how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The scale is from 0 to 5. Higher scores mean a worse outcome. | 2.5 year after randomization |
| Complications | Complications 1 week after operation were assessed. The complications after operation include headache, nausea, vomit, myodynamia, seizer, and so on. | within 1 week after operation |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |