brain metastases
Conditions
Interventions
control group:Systemic treatment was performed after simultaneous dose-modulated intensity-modulated radiotherapy of the whole brain according to the pathology of the primary lesion
experimental group:Temozolomide for injection plus whole-brain synchronous dose-modulated intensity radiotherapy, followed by 4 cycles of TMZ chemotherapy
Sponsors
Zhengzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before enrollment; 2. Aged from 18-75 years. male or female; 3. Histopathology confirmed that the primary tumor was malignant, and the primary tumor was stable after first-line treatment. Craniocerebral lesions were confirmed as brain metastasis by imaging (MRI, PET-CT, CT), and there were measurable lesions (according to RECIST version 1.1 standards) with less than or equal to 5 metastases and at least one measurable lesion; 4. KPS >= 70; 5. Blood routine parameters: a. WBC >= 4.0 x 10^9/L b. Neutrophils >= 1.5 x 10^9/L c. Hb >= 110g/L d. PLT >= 100 x 10^9/L; 6. Normal renal function:Cr = 60 mL /min; 7. Normal liver function: TBIL <= 1.5ULN, ASAT & ALAT <= 1.5 ULN.
Exclusion criteria
Exclusion criteria: 1. The trial had received temozolomide treatment, craniocerebral radiotherapy and craniocerebral surgery before treatment; 2. Patients who do not understand the requirements of the test or may not comply with treatment; 3. Patients with uncontrolled diabetes, hypertension, and severe cardiovascular or pulmonary disease; 4. Survival is expected to be less than three months; 5. Pregnant or nursing women; 6. Patients with allergy to temozolomide; 7. Patients who have participated in clinical trials of other drugs within 30 days; 8. There are some obvious diseases that the researchers consider to be excluded from this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial progression free survival, IPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Brain metastasis specific survival rate, BMSS;Local control rate, LC;Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactHan Quanxiang
Zhengzhou Central Hospital
Outcome results
None listed