brain metastases
Conditions
Interventions
single arm:temozolomide combined with hyperfration radiotherapy
Sponsors
The First Affiliated Hospital of Da lian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18-75 years. male or female; 2. Has histopathological or cytologically proven primary cancer with accompanying brain metastasesProvide a detailed report of the pathology of the primary cancer; 3. Determine brain metastases by imaging examination, according to RECIST 1.1 standard, at least one target lesion that can be measured / evaluated in the brain. 4. No temozolomide treatment has been performed before, or disease progression occurred after temozolomide discontinuation for 6 months or disease progression occurred after stopping adjuvant therapy by temozolomide for 1 year. 5. Previous radiotherapy and chemotherapy, targeted therapy, immunotherapy are not limited 6. KPS >= 60. 7. Life expectancy >= 6 months. 8. The functions of vital organs meet the following requirements. (1) Blood routine parameters: a. WBC >= 3.5 x 10^9/L b. Neutrophils >= 1.5 x 10^9/L c. Hb >= 90g/L d. PLT >= 100 x 10^9/L (2) Blood biochemical parameters: a. TBIL <= 1.5ULN b. ALT and AST <= 2.5 ULN (if the abnormal liver function was caused by liver metastasis, ALT and AST <= 5 ULN can be accepted) c. Cr <= 1.5 x ULN, BUN <= 1.5 x ULN (3) Coagulation function: INR <= 1.5 and APTT <= 1.5ULN 9. Subjects sign informed consent and voluntarily comply with visits, treatment protocols, laboratory tests defined by the schedule and other requirements for the study.
Exclusion criteria
Exclusion criteria: Patients with any of the following cannot be recruited in this study: 1. The primary focus is central system tumor, including but not limited to LGG and HGG. 2. Patients with allergy to temozolomide and/or its excipients. 3. Patients evaluated of PR for brain metastatic lesions after systemic treatment need Suspend head radiotherapy. 4. Patients with a clear bleeding tendency, including but not limited to having local active ulcer lesion and fecal occult blood(++), and patients with history of black stool and hematemesis within 2 months. 5. Patients with a history of psychoactive drug abuse and cannot give up, or patients with mental disorders. 6. Patients who have participated in clinical trials of other drugs within 4 weeks. 7. Patients with active infection and required systemic treatment. 8. Patients with positive HBsAg and peripheral blood HBV-DNA >= 1x103copies/mL . Patients with positive HBsAg and peripheral blood HBV-DNA < 1 x 103copies/mL can be recruited only when their chronic hepatitis B was considered stable and no increasing risk by the investigator. Patients with positive HCV or HIV. 9. Patients with severe cardiovascular and cerebrovascular thromboembolism within 6 months before recruiting.(e.g. myocardial infarction, unstable angina, stroke) 10. Female patients with positive blood pregnancy test during screening(patients of childbearing age must agree to take effective contraceptive measures during the trial). 11. Pregnant or nursing women. 12. According to the judgment of the investigator, there are other concomitant diseases, previous history or other factors that seriously endanger the safety of the patient or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ObjectiveResponseRate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression-Free Survival;Quality of life score;Drug safety; | — |
Countries
China
Contacts
Public ContactYiqian Wang
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed