Glioblastoma
Conditions
Interventions
Treatment Group:hypofractionated stereotactic radiotherapy by cyberknife following tumor treatment fields (TTF)
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Age >=65 years, KPS>=50; 2)Glioblastoma confirmed by surgery or pathological biopsy, WHO grade IV; 3)The methylation status of MGMT promoter is clear; 4)No radiotherapy or chemotherapy except surgery (including biopsy); 5)Diffuse dissemination and distant metastasis have been ruled out; 6)No previous radiotherapy or chemotherapy for any intracranial tumor; 7)Life expectancy>=3 months; 8)Patients receiving corticosteroids were enrolled in a dose stabilization or reduction phase; 9)The main organs function well, and the examination indicators meet the following requirements: Blood routine examination: a) hemoglobin >=90 g/L (no transfusion within 14 days); b) neutrophil count >=1.5×10^9/L; c) platelet count >=80×10^9/L; Biochemical tests: d) Total bilirubin = 50 ml/min (Cockcroft-Gault formula); 10)The patient has no recent desire to have children; 11)Voluntary signing of informed consent; 12)Good compliance to complete follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of other malignant diseases in the past 3 years, except cured skin cancer and cervical carcinoma in situ; 2. Metal foreign bodies such as bullet fragments and implanted electronic medical equipment, including deep brain stimulators, spinal cord stimulators, cardiac pacemakers and defibrillators; 3. Patients with any unstable systemic disease (including active infection, poorly controlled moderate to severe hypertension, unstable angina pectoris, congestive heart failure, liver or kidney, or metabolic disease) that causes intolerance to radiation therapy; 4. For patients with a history of uncontrolled mental disorders, the clinical severity, as judged by the investigator, may prevent the signing of the informed consent form or affect the patient's compliance with treatment; 5. Pregnant or lactating women; 6. Any bleeding event with a severity grade of CTCAE 4.0 of Grade 3 or higher within 4 weeks prior to screening; 7. Hypertension that is not well controlled with a single antihypertensive drug (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg); history of unstable angina pectoris; newly diagnosed angina pectoris within 3 months prior to screening or myocardial infarction within 6 months prior to screening; arrhythmia (including QTcF: >=450 ms for men) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade =II cardiac insufficiency; 8. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the patient's tumor has a high possibility of invading important blood vessels during treatment and causing fatal massive bleeding; 9. History of immune deficiency, or other acquired, congenital immune deficiency disease, or history of organ transplantation; 10. Concomitant diseases that, in the judgment of the investigator, seriously jeopardize patient safety or affect patient completion of the study; 11. Patient is allergic to conductive gel; 12. Patients who do not meet the inclusion criteria or who are considered unsuitable for the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Objective response rate, ORR;AEs;Cognitive function;Quality of life; | — |
Countries
China
Contacts
Public ContactZhiyong Qin; Xin Wang
Huashan Hospital affiliated to Fudan University
Outcome results
None listed