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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
NCT01410370 |
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Date of registration:
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20/07/2011 |
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Primary sponsor: |
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Public title:
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Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases
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Scientific title:
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Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01410370 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Xiaodong Jiang, MD |
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Address:
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Telephone:
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0518-85605120 |
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Email:
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Affiliation:
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Name:
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Xiaodong Jiang, MD |
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Address:
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Telephone:
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86-0518-85605120 |
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Email:
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Affiliation:
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Name:
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Xiaodong Jiang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First People's Hospital of Lianyungang |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Brain Metastases
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Intervention(s)
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Drug: Endostar
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Radiation: 6MV-X ray
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Primary Outcome(s)
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Objective Response Rate (ORR)
[Time Frame: 1 month after initial treatment]
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Secondary Outcome(s)
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Cerebral Edema
[Time Frame: 1 month after initial treatment]
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Incidence of Adverse Events
[Time Frame: up to 1 month after last dose]
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Overall Survival
[Time Frame: 2 year]
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Serum VEGF Levels
[Time Frame: at baseline and 1 month after initial treatment]
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VEGF levels in tumor tissue
[Time Frame: at baseline and 1 month after initial treatment]
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Secondary ID(s)
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Endu-201107
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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