Clinical trial NCT04417933: Tumor Electric Fields Treatment System for Glioblastoma
Official title: A Prospective, Single-center, Single-arm, Exploratory Study on the Treatment of Recurrent Glioblastoma With Tumor Electric Fields Treatment System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Glioblastoma
Keywords: glioblastoma
tumor electric fields treatment
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Hunan An Tai Kang Cheng Biotechnology Co., Ltd
First posted: 2020-06-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with pathological diagnosis of glioblastoma at first surgery (WHO Grade IV, supratentorial location);
* Age between 18 and 65 years, male or female;
* Previously completed radiotherapy and at least two cycles of chemotherapy;
* With imaging or pathological evidence of tumor recurrence;
* Karnofsky performance score (KPS) score ≥ 70 before intervention;
* With a life expectancy more than 3 months;
* Adopted effective contraceptive measures at child-bearing age;
* Provided written informed consent.

Exclusion Criteria:

* Patients unwilling to use the equipment ≥ 18h per day;
* With poor compliance or live too far from the research center, who cannot keep regular follow-up or adjust the electrode position of the treatment equipment, and who refuse to receive follow-up to terminal survival;
* With poor healing of scalp wound, poor scalp condition, large skull defect or other cases where electrodes are not suitable for wearing;
* Within 3 months from radiotherapy;
* Within 4 weeks from the last cycle of chemotherapy;
* Within 4 weeks from surgery for recurrence;
* Participated in other clinical trials.
* Pregnant;
* Epilepsy symptoms not effectively controlled;
* Blood and biochemical indicators in the following range: A. Liver function impairment: AST or ALT \> 3 times the upper limit of normal; B. Total bilirubin\> upper limit of normal value; C. Renal impairment: serum creatinine\>1.7mg /dL (\>150 mol/L); D. Coagulopathy: PT or APTT \>1.5 times normal; E. Platelets counts \< 100x10\^9/L; F. Absolute neutrophils count \< 1x10\^9/L; G. Hemoglobin \< 100g/L;
* With severe infectious diseases, such as acute severe infection and HIV positive;
* Other conditions, such as an implanted cardiac pacemaker or deep brain stimulator, severe intracranial edema, increased intracranial pressure resulting in midline shift\>5mm, clinically significant papilledema, or reduced level of consciousness, allergy to conductive coupling agent, gel, and other serious life-threatening diseases.
* Other circumstances considered inappropriate to participate in the research by the investigator.

Primary outcomes:
measure: The treatment-related adverse events
timeFrame: 12 months
measure: Time to Progression
timeFrame: 12 months
measure: Overall Survival Rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
References: