Tumor Electric Fields Treatment System for Glioblastoma

NCT04417933 | Unknown Early Phase 1

• 1 other identifier: 202001012
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

glioblastoma; tumor electric fields treatment

Outcome Measures

Primary Outcomes (3)

• The treatment-related adverse events

  Number of patients who experienced a treatment-related adverse event.

  12 months

• Time to Progression

  Time to progression of patients with recurrent glioblastoma.

  12 months

• Overall Survival Rate

  Number of patients alive at 12 months.

  12 months

Study Arms (1)

Tumor Electric Fields Treatment System

EXPERIMENTAL

Patients have a histologically confirmed diagnosis of supratentorial glioblastoma that is recurrent. All patients will receive Tumor Electric Fields Treatment System.

Device: Tumor Electric Fields Treatment System

Interventions

Tumor Electric Fields Treatment System DEVICE

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.

Also known as: ASCLU-300

Tumor Electric Fields Treatment System

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Hunan An Tai Kang Cheng Biotechnology Co., Ltd: collaborator

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Zhixiong Liu, M.D.

CONTACT

+8613607318785; zhixiongliu@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 5, 2020
• Study Start: April 7, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-05

Locations

CN (1)