Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases
NCT ID: NCT01410370
Last Updated: 2013-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2011-06-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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treatment
Radiotherapy plus Endostar
6MV-X ray
3Gy/time, 5 times/week, a total of 10 times
Endostar
7.5mg/m2/d, continuous infusion, in parallel with radiotherapy
control
Radiotherapy
6MV-X ray
3Gy/time, 5 times/week, a total of 10 times
Interventions
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6MV-X ray
3Gy/time, 5 times/week, a total of 10 times
Endostar
7.5mg/m2/d, continuous infusion, in parallel with radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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The First People's Hospital of Lianyungang
OTHER
Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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The First People's Hospital of Lianyungang
Principal Investigators
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Xiaodong Jiang, MD
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Lianyungang
Locations
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The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Countries
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Central Contacts
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Xiaodong Jiang, MD
Role: CONTACT
Facility Contacts
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Xiaodong Jiang, MD
Role: primary
Other Identifiers
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Endu-201107
Identifier Type: -
Identifier Source: org_study_id
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