This early phase I trial will investigate the safety and feasibility of applying the Tumor Electric Fields Treatment System to subjects with recurrent glioblastoma.
Subjects who have previously completed radiotherapy and at least two cycles of chemotherapy with imaging or pathological evidence of tumor recurrence will receive Tumor Electric Fields Treatment System. The main objective is to evaluate the safety of applying the Tumor Electric Fields Treatment System to subjects with recurrent GBM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
Patients wear two pairs of electrodes on the head for 19-22 hours a day. Each patient is required to wear the device as long as possible and not less than 6 months. The treatment has a two-day break for every four weeks.
Xiangya Hospital Central South University
Changsha, Hunan, China
RECRUITINGThe treatment-related adverse events
Number of patients who experienced a treatment-related adverse event.
Time frame: 12 months
Time to Progression
Time to progression of patients with recurrent glioblastoma.
Time frame: 12 months
Overall Survival Rate
Number of patients alive at 12 months.
Time frame: 12 months
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