NCT04417933

Tumor Electric Fields Treatment System for Glioblastoma

A Prospective, Single-center, Single-arm, Exploratory Study on the Treatment of Recurrent Glioblastoma With Tumor Electric Fields Treatment System

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial will investigate the safety and feasibility of applying the Tumor Electric Fields Treatment System to subjects with recurrent glioblastoma.

Detailed description

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DEVICE	Tumor Electric Fields Treatment System	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.

Timeline

• Start date: 2020-04-07
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-06-05
• Last updated: 2020-06-11

Locations

1 site across 1 country: China