Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

NCT ID: NCT01410370

Last Updated: 2013-04-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment

Radiotherapy plus Endostar

Group Type EXPERIMENTAL

6MV-X ray

Intervention Type RADIATION

3Gy/time, 5 times/week, a total of 10 times

Endostar

Intervention Type DRUG

7.5mg/m2/d, continuous infusion, in parallel with radiotherapy

control

Radiotherapy

Group Type ACTIVE_COMPARATOR

6MV-X ray

Intervention Type RADIATION

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

Intervention Type RADIATION

Endostar

7.5mg/m2/d, continuous infusion, in parallel with radiotherapy

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First People's Hospital of Lianyungang

OTHER

Sponsor Role collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaodong Jiang, MD

Role: CONTACT

86-0518-85605120

Facility Contacts

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Xiaodong Jiang, MD

Role: primary

0518-85605120

Other Identifiers

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Endu-201107

Identifier Type: -

Identifier Source: org_study_id

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