Glioblastoma, Glioma
Conditions
Keywords
glioblastoma, TTFields, radiotherapy
Brief summary
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
the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.
Interventions
DEVICETTFields
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.
Sponsors
Zhongnan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 1 year | the length of time after primary treatment for glioblastoma ends that the patient survives without any signs or symptoms of glioblastoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | The length of time from the date of diagnosis to death from cancer |
Countries
China
Contacts
Primary ContactYahua Zhong, PHD
Outcome results
None listed