Newly diagnosed glioblastoma
Conditions
Interventions
Test :Tumor Treating Fields + Temozolomide
Control:Temozolomide
Sponsors
Huashan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Patients with GBM confirmed by pathological examination after brain surgery (patients with total, partial and biopsy are acceptable) and according to the 2021 World Health Organization (WHO) classification criteria.IDH wild-type and astrocytoma, IDH mutant, WHO 4 grade subjects; (2) Aged=18 years,Male or female; (3) Supra-tentorial tumors; (4) Standard concomitant chemoradiotherapy has been completed; (5) Karnofsky scale = 70; (6) Life expectancy at least 3 months; (7) Participants of childbearing age must use effective contraception; (8) Subjects can understand the whole test process and sign informed consent form.
Exclusion criteria
Exclusion criteria: (1) Severe mental or neurological disease or cognitive impairment due to mental illness, resulting in inability to understand or comply with the requirements of the trial and inability to sign the informed consent; (2) Patients who are breastfeeding, pregnant or planning to become pregnant during the trial; (3)Subjects who have implanted or will implanted electronic medicial devices (including but not limited to pacemakers, implantable cardioverter defibrillators, brain stimulators, insulin pumps, spinal cord stimulators, vagus nerve stimulators, etc.); (4)Subjects who are currently participating in and accepting other interventional clinical trials and have an impact on efficacy evaluation; (5)History of hypersensitivity reaction to conductive hydrogel or a history of hypersensitivity to TMZ; (6)Imaging and symptom evidence of increased intracranial pressure:midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness; (7)Received any other cytotoxic or biologic antitumor therapy other than synchronous TMZ chemoradiotherapy within 28 days prior to enrollment; (8)Subjects with severe cardiac insufficiency; (9) Subjects must have appropriate organ function before enrollment, and will not be enrolled if any of the following conditions are met: Hematology function: neutrophil absolute value 2 times the upper limit of normal (ULN); Liver function: aspartate transaminase (AST) >3 times the upper limit of normal (ULN), alanine aminotransferase (ALT)>3 times the upper limit of normal (ULN), total bilirubin >2 times the upper limit of normal(ULN); (10) Complicated with acute severe infection; (11) Infra-tentorial tumor; (12)Progressive disease occurred after the end of concomitant radiochemotherapy, or a state of suspected disease progression requiring medical intervention; (13)Subjects treated with steroid hormones within 14 days prior to enrollment; (14)Subjects who have had other malignancies within the past 5 years, other than locally curable cancers that have undergone radical treatment, such as basal or squamous cell skin cancer, superficial bladder cancer or cancers in situ of the prostate, cervix or breast; (15) Any situation that the investigator believes is likely to affect the evaluation of the trial or have adverse effects on participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate;One-year survival rate;Overall survival;Quality of life assessment;Device performance evaluation; | — |
Countries
China
Contacts
Public ContactQin Zhiyong
Huashan Hospital affiliated to Fudan University
Outcome results
None listed