Glioblastoma
Conditions
Interventions
Group A:Tumor treating fields (MF-I-100B) >=18 hours/day + temozolomide adjuvant chemotherapy for 6 cycles
Group B:Tumor treating fields (MF-I-100B) on days 1-3 of each week (>=22 hours/day, cumulative >=72 hours/week) + temozolomide adjuvant chemotherapy for 6 cycles
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged >=18 years and ==3 months. 8.Supratentorial tumor. 9.Karnofsky Performance Score (KPS) >=70. 10.Corticosteroid dose stable or reduced within 7 days prior to enrollment. 11.Able to operate the tumor treating fields device independently or with the assistance of a caregiver. 12.Subject or guardian able to understand the study purpose, demonstrate sufficient compliance with the protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Early progression of GBM after completion of standard concurrent chemoradiotherapy (RT+TMZ) (if pseudoprogression is suspected, imaging should be used to further rule it out). 2.Other cancers requiring anti-tumor therapy within 5 years prior to enrollment, excluding treated stage I prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, and non-melanoma skin cancer. 3.Laboratory findings meeting any of the following: a. Neutrophil count (NEUT) 1.5× upper limit of normal (ULN); d. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5× ULN; e. Serum creatinine (Scr) >1.5× ULN. 4.History of active implanted devices or intracranial metal implants. 5.History of allergy to medical adhesives or hydrogels. 6.Complicated with systemic infection or uncontrolled local infection, or other vital organ (heart, lung, liver, kidney) failure. 7.Active scalp infection, inflammation, etc., that prevents electrode patch application for electric field therapy. 8.Uncontrolled psychiatric history that may affect the treatment process as judged by the investigator. 9.Infratentorial tumor. 10.Pregnant or lactating women. 11.Participation in another drug clinical trial within 3 months prior to enrollment, or another device clinical trial within 1 month prior to enrollment. 12.Other conditions that the investigator deems inappropriate for participation in this trial for the subject's best interest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month Progression-Free Survival Rate;12-month Overall Survival Rate;Best Objective response evaluation of glioma (RANO criteria);Subject Compliance; | — |
Countries
China
Contacts
Public ContactQin Zhiyong
Huashan Hospital, Fudan University
Outcome results
None listed