Tumor Electric Fields Treatment System for Glioblastoma

  • STATUS
    Recruiting
  • participants needed
    5
  • sponsor
    Xiangya Hospital of Central South University
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Updated on 19 February 2024
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glioblastoma multiforme
recurrent tumor
recurrent glioblastoma

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.

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.

Details
Condition Glioblastoma Multiforme, Glioblastoma Multiforme
Age 18-65 years
Treatment Tumor Electric Fields Treatment System
Clinical Study IdentifierNCT04417933
SponsorXiangya Hospital of Central South University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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