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TTFields has been approved by the FDA for the treatment of patients with glioblastoma multiforme. However, the clinical effect and safety of radiotherapy concurrent of TTFields is not definite. In this study, the investigators conduct a phase II clinical trial to evaluate the efficacy and safety of this strategy.
the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E group | Experimental | All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT）and TTFields therapy during RT. The TTFields therapy started on the day the radiotherapy started. |
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| C group | No Intervention | All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT） |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTFields | Device | The TTFields, consisting of low-intensity, 200 kHz frequency, alternating electric fields, was delivered (≥ 18 hours/d) via 4 transducer arrays on the shaved scalp and connected to a portable device. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | the length of time after primary treatment for glioblastoma ends that the patient survives without any signs or symptoms of glioblastoma. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The length of time from the date of diagnosis to death from cancer | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yahua Zhong, PHD | Contact | 08602767813154 | doctorzyh73@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianyin Huang, MD | Wuhan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan hospital | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |