Glioblastoma Multiforme
Conditions
Interventions
Experimental group:Tumor Treating Fields + Temozolomide
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed supratentorial glioblastoma (WHO grade iv) or astrocytoma (WHO grade iv) confirmed by histology/molecular pathology (including single and multiple lesions, graded according to The 2016 World Health Organization Classification of Tumors of the Central Neuvous System or cIMPACT-NOW UPDATE5); 2. Concomitant TMZ radiochemotherapy was started within 6 weeks (= 22 years, male or female; 4. Karnofsky scale >= 50; 5. Life expectancy >= 3 months; 6. The steroid dose was stable or decreased within 1 week before enrollment; 7. Voluntarily participate in the clinical trial, and have signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Implanted electronic devices, including but not limited to pacemakers, implantable cardioverter defibrillators, insulin pumps, brain stimulators, spinal cord stimulators, or vagus nerve stimulators; 2. Significant co-morbidities at baseline: (1)Thrombocytopenia (platelet count 3 times the upper limit of normal); (5)Total bilirubin > 2 times the upper limit of normal; (6)Significant renal impairment (serum creatinine > 1.7 mg/dL). 3. Subject with acute severe infection; 4. Subject with severe cardiac insufficiency; 5. CT, MRI or other imaging evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness); 6. History of hypersensitivity reaction to Temozolomide; 7. Subject with neurological, mental disorders or other diseases leading to incompliance with the treatment; 8. Allergic to conductive hydrogel or other condition which is unsuitable for wearing transducer arrays; 9. Participation in other clinical trials within 90 days prior to screnning; 10. Lactating women, pregnant women or recent planned parenthood; 11. Early progressive disease occurred after the end of concomitant radiochemotherapy. The suspected pseudoprogression need to be excluded by imaging examination; 12. Subjects had received any other cytotoxic or biological anti-tumor therapy except for concomitant TMZ radiochemotherapy before enrollment; 13. Infra-tentorial tumors; 14. Subject who is inappropriate to paticipate in the clincial trial judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;6-month progression-free survival rate;1-year and 2-year survival rates;Quality of Life Scale;Instrument performance evaluation; | — |
Countries
China
Contacts
Public ContactQiu Xiaoguang
Outcome results
None listed