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The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:
Participants will:
The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:
Participants will:
Step 1:
Step 2:
Researchers will compare the overall survival of each arm to see if TTFields demonstrates an improvement in survival outcomes within the Chinese population in real-world practice, and whether this efficacy is further enhanced when combined with RT and TMZ.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTFields-Total | Patients receive standard RT + TMZ, followed by maintenance TMZ, with Optune® starts during peri-radiotherapy period (2 month before to 3 months after radiotherapy). The duration of TTFields lasts for at least 2 months. |
| |
| Active Comparator: Temozolomide alone | Patients receive RT and TMZ alone, followed by maintenance TMZ. | ||
| TTFields-concomitant | Patients receive TTFields at 200 kHz to the brain using the Optune® System together with RT and TMZ, followed by maintenance TMZ concomitant with the Optune® treatment. The duration of TTFields lasts for at least 2 months. If the subject is assigned to this treatment arm, Optune® therapy will begin no later than the 7th day of RT and TMZ treatment. |
| |
| TTFields-adjuvant | Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant with TTFields at 200 kHz to the brain using the Optune® within 3 months after radiotherapy for at least 2 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optune® (Tumor Treating Fields) | Device | TTFields at 200 kHz to the brain using the Optune® System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Survival will be measured from the time of randomization until date patient is alive. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are diagosed and whose surgery and radiotheraoy are finished in West China Hospital, Sichuan Cancer Hospital, Shenzhen People's Hospital, Henan Cancer Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University
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| Name | Affiliation | Role |
|---|---|---|
| Lei Liu, PhD, MD | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Chengdu | Sichuan | 610041 | 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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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |