Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma

Study Overview
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Brief Summary
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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.

Detailed Description
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the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.

Official Title
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The Clinical Effect and Safety of Radiotherapy Concurrent of TTFields in the Treatment of Post-operation Patients With Glioblastoma.

Conditions
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Glioma, Glioblastoma

Intervention / Treatment
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* Device: TTFields


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: performance status of 0-1 (Eastern Cooperative Oncology Group performance status) histologically confirmed glioblastoma no cerebrospinal fluid and distant metastatic disease. Exclusion Criteria: with a history of brain radiotherapy severe hepatic and renal dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E group<br>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. | Device: TTFields<br>* 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.<br>|
| No Intervention: C group<br>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） | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The length of time from the date of diagnosis to death from cancer | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glioblastoma, TTFields, radiotherapy