Brain Metastases
Conditions
Keywords
Endostar, Radiotherapy, Brain Metastases
Brief summary
The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.
Interventions
RADIATION6MV-X ray
3Gy/time, 5 times/week, a total of 10 times
DRUGEndostar
7.5mg/m2/d, continuous infusion, in parallel with radiotherapy
Sponsors
The First People's Hospital of Lianyungang
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed malignancy with presence of intraparenchymal brain metastases * Karnofsky performance status ≥ 40 * Measurable disease according to RECIST criteria * Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L * Renal function: Cr ≤ 2.0×ULN * Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN * Adequate cardiac function * Life expectancy ≥ 3 months
Exclusion criteria
* Evidence of bleeding diathesis or serious infection * Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) * Uncontrollable mental and nervous disorders * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | 1 month after initial treatment |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 2 year |
| Serum VEGF Levels | at baseline and 1 month after initial treatment |
| VEGF levels in tumor tissue | at baseline and 1 month after initial treatment |
| Incidence of Adverse Events | up to 1 month after last dose |
| Cerebral Edema | 1 month after initial treatment |
Countries
China
Contacts
Primary ContactXiaodong Jiang, MD
Outcome results
None listed