Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

NCT ID: NCT01368419

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-05-31

Brief Summary

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This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.

Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

Endostar

Intervention Type DRUG

75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks

Radiotherapy

Intervention Type RADIATION

6~15MV X-ray, 2Gy/time,5times/week,6 weeks

Interventions

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Endostar

75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks

Intervention Type DRUG

Radiotherapy

6~15MV X-ray, 2Gy/time,5times/week,6 weeks

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological diagnosis of previously untreated stage I-III esophageal cancer
* Measurable disease according to RECIST criteria
* ECOG Performance Status 0-1
* The length of esophageal carcinoma ≤ 10 cm
* Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
* Renal function: Cr ≤ 2.0×UNL
* Hepatic function: BIL ≤ 2.0×UNL, ALT/AST ≤ 5.0×UNL

Exclusion Criteria

* Pregnant or lactating women
* Evidence of bleeding diathesis, 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
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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Responsibility Role SPONSOR

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-201105

Identifier Type: -

Identifier Source: org_study_id

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