Recurrent GBM
Conditions
Interventions
exprimental group:PETF + Temozolomide
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be included: 1. Supratentorial tumor; 2. Patients with recurrent GBM diagnosed after standard treatment (surgery and stump regimen); 3. Patients with evaluable tumor lesions or patients who received surgical treatment after recurrence according to Rano criteria; 4. Patients with age >= 18 years old and = 60; 6. Subjects without implantable devices (deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, cardiac pacemaker, cardiac defibrillator, etc.); 7. Subjects with the largest diameter of skull defect less than 3cm; 8. The subjects were fully aware of the benefits and risks of the trial, and were still willing to participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria will not be enrolled in the study: 1. Estimated lifetime 1.5*ULN, alanine aminotransferase > 2.5*ULN, alanine aminotransferase > 2.5*ULN; C. Renal function: creatinine > 1.5*ULN and creatinine clearance 1.5×ULN (using Cockcroft Gault formula to calculate creatinine clearance); 11. Systolic blood pressure > 150mmHg or diastolic blood pressure > 100mmHg after taking antihypertensive drugs; 12. Subjects who have history of substance abuse or drug abuse; 13. Subjects who were HBsAg or HBcAb positive, and peripheral blood HBV DNA titer test >= 1*10^3IU/mL; 14. Subjects who have positive items of HCV, treponema Pallidum antibody or HIV antibody; 15. Subjects who had other malignant tumors (excluding adequately treated carcinoma in situ of the cervix, squamous cell carcinoma of the skin and adequately controlled localized basal cell skin cancer) within 5 years prior to enrollment; 16. Subjects who have been treated with temozolomide dose density regimen; 17. Subjects who are allergic to temozolomide or cannot receive temozolomide treatment for other reasons; 18. The blood pregnancy test results of female subjects during non-breastfeeding period and within 7 days before the treatment of the first study were positive. Subjects (male or female) refuse to commit to using at least one acceptable contraceptive method (i.e., intrauterine devices, condoms, hormonal contraceptives of any kind, abstinence, etc.) throughout the study period and for 3 months following the last study treatment; 19. Subjects who were judged ineligible for enrollment in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;One-year Survival Rate;Eight-Week Disease Control Rate;Eight-Week Objective Response Rate; | — |
Countries
China
Contacts
Public ContactWenbin Li
Beijing Tiantan Hospital Affiliated to Capital Medical University
Outcome results
None listed